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- Recall Enforcement Event ID: 74187
Recall Enforment Report D-1009-2016
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Well Care Compounding Pharmacy, originally initiated on 05-17-2016 for the product SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 The product was recalled due to lack of assurance of sterility: fda inspection identified gmp violations potentially impacting product quality and sterility.. The product was distributed in Nv and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1009-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1019-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0998-2016 | 05-17-2016 | 06-15-2016 | Class II | N/A | M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1006-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0980-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (All Products) | ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1003-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0989-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | 1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0988-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | 1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1015-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0983-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1000-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1017-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0984-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0995-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0981-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0979-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1024-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1022-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1010-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1023-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1005-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1002-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0985-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0978-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 units (total all products) | 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1007-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0990-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1021-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0996-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1028-2016 | 05-17-2016 | 06-15-2016 | Class II | 916 total units | ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1008-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1014-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1026-2016 | 05-17-2016 | 06-15-2016 | Class II | 916 total | CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0991-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1012-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0999-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1016-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1004-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1025-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1027-2016 | 05-17-2016 | 06-15-2016 | Class II | 916 total units | ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1001-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0992-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0997-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1011-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0986-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0993-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0987-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0994-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-0982-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1018-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1013-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
| D-1020-2016 | 05-17-2016 | 06-15-2016 | Class II | 869 Units (Total All Products) | TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Terminated |
Recall Enforcement Report D-1009-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1009-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01062016:29@49, Exp.04/06/2016; Lot #: 02032016: 30@5, Exp.05/03/2016; Lot #: 03312016:91@17; Exp. 06/29/2016; Lot #: 03302016:17@40, Exp. 06/30/2016; Lot 4132016:46@20, Exp. 07/12/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1019-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1019-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 03022016:16@45, Exp. 06/01/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0998-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0998-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01272016:00@24, Exp.03/28/2016; Lot #: 03292016: 96@35, Exp. 05/24/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1006-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1006-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01292016:04@9, Exp.07/27/2016; Lot #: 04082016: 84@17, Exp. 10/09/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0980-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0980-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 03252016:11 @26, Exp. 05/07/2016; Lot #: 04042016:28 @39, Exp. 05/06/2016; Lot #: 02102016:00 @22, Exp. 03/24/2016; Lot #:02112016:08 @13, Exp. 03/16/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1003-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1003-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01112016:29@20, Exp. 01/19/2016; Lot #:01202016: 85@9, Exp. 01/27/2016; Lot #: 01222016: 56@17, Exp. 01/29/2016; Lot #: 01222016:36@49, Exp.02/02/2016; Lot #: 01262016:72@12, Exp.02/02/2016; Lot #: 01262016: 56@58, Exp.02/03/2016; Lot #: 02052016:89@26, Exp.03/02/2016; Lot #: 02112016:55@39, Exp.03/03/2016; Lot #: 02102016: 95@17, Exp. 03/08/2016; Lot #: 02222016:39@46, Exp. 03/15/2016; Lot #: 04222016:40@48, Exp.03/16/2016; Lot #: 02262016:53@13, Exp.03/24/2016; Lot #: 03072016: 01@14, Exp. 03/29/2016; Lot #: 03082016:40@11, Exp.03/30/2016; Lot #: 3012016:90@30, Exp.04/07/2016; Lot #: 03012016:78@13, Exp.04/18/2016; Lot #: 03222016: 19@17 04/13/2016; Lot #: 0331201661@40, Exp.04/21/2016; Lot #: 04132016:89@17, Exp. 05/06/2016; Lot #: 04272016:35@45, Exp. 05/20/2016; Lot #: 04292016:70@27, Exp.05/23/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0989-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0989-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 032520164: 7@1, Exp 06/23/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0988-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0988-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01072016: 23@28, Exp. 04/06/2016; Lot #: 01082016: 27@1, Exp. 04/07/2016; Lot #:02012016:20@39, Exp. 05/01/2016; Lot #: 02022016:07@7, Exp.05/02/2016; Lot #: 02152016:29@50, Exp. 05/15/2016; Lot #: 02292016: 40@24, Exp.05/29/2016; Lot #: 02292016: 12@42 , Exp.05/29/2016; Lot #: 03042016:96@9, Exp.06/02/2016; Lot #: 03082016:59@34, Exp.06/08/2016 03142016:65@58, Exp.06/12/2016; Lot #: 03212016: 66@2, Exp.06/19/2016; Lot #: 03022016:50@38, Exp.06/23/2016; Lot #: 03302016: 93@11, Exp. 06/28/2016; Lot #: 04062016:79@22, Exp.07/07/2016; Lot #: 04122016 38@58, Exp.07/12/2016; Lot #: 04152016: 87@1, Exp. 07/14/2016; Lot #: 04152016:12@12, Exp. 07/14/2016; Lot #: 04222016: 55@27, Exp.07/21/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1015-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1015-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01142016:19@26, Exp. 04/14/2016; Lot #: 02032016:23@32, Exp. 05/05/2016, Lot #: 02092016:17@9, Exp.06/10/2016; Lot #: 04262016: 11@16, Exp. 07/27/2016; Lot #: 01112016:65@70, Exp.04/10/2016; Lot #: 01202016:57@46, Exp.04/19/2016; 01212016:08@34, Exp. 04/28/2016; Lot: 02082016:08@27, Exp.05/08/2016; Lot #: 02222016:82@50, Exp.05/22/2016 03142016:75@24, Exp. 06/14/2016; Lot #: 03212016:07@73, Exp. 06/26/2016 03232016:47@23, Exp. 06/28/2016; Lot #: 04062016:96@28, Exp. 07/06/2016 04132016:@46 , Exp. 07/13/2016; Lot #: 04192016:92@1, Exp.07/19/2016 04272016:63@11, Exp.07/26/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0983-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0983-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 04112016:76@67, Exp.07/12/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1000-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1000-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01062016: 32@16, Exp.04/06/2016; Lot #: 01252016: 96@51, Exp. 07/23/2016; Lot #: 03302016: 68@42, Exp. 09/25/2016; Lot #: 04042016:11@27, Exp.10/02/2016; Lot #: 04122016: 90@15, Exp. 10/09/2016 04202016:57@13, Exp.10/22/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1017-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1017-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 11162016:19@6, Exp.02/15/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0984-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0984-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02162016:85@45, Exp. 5/17/2016; Lot #:03092016:30@19, Exp. 06/07/2016; Lot #: 01282016:77@25, Exp.05/03/2016; Lot #: 3112016:98@21, Exp. 06/13/2016; Lot #:03242016:52@22, Exp. 06/27/2016; Lot #: 04122016:15@50, Exp. 7/11/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0995-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0995-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01222016:57@21, Exp.03/33/2016; Lot #: 01222016: 78@51, Exp.04/25/2016; Lot #: 01272016:51@23, Exp. 03/27/2016; Lot #: 02292016:71@13, Exp. 04/29/2016; Lot #: 03022016:46@14, Exp. 06/22/2016; Lot #:04252016:20@62, Exp.06/24/2016; Lot #: 04262016:18@11, Exp.06/25/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0981-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0981-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 03302016:68@10, Exp.06/28/2016; Lot #: 03082016:83@38, Exp. 06/06/2016; Lot #:02172016:37@51, Exp. 5/17/2016; Lot #: 2102016:80@55, Exp.5/30/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0979-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0979-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01252016:40@31, Exp. 04/27/2016; Lot #: 03072016:78@19, Exp. 06/6/2016; Lot #: 02222016:71@35, Exp. 05/27/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1024-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1024-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01052016:13@44, Exp.03/07/2016; Lot #: 01052016: 06@43, Exp. 04/13/2016; Lot #: 04052016:84@24; Exp. 06/06/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1022-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1022-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01182016:09@28, Exp. 02/01/2016; Lot #: 03072016:50@49, Exp. 03/21/2016; Lot #: 03232016: 79@7, Exp. 04/06/2016; Lot #:03282016:15@10, Exp. 04/11/2016; Lot #: 04192016:35@14, Exp.07/19/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1010-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1010-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 03022016:16@45, Exp. 06/01/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1023-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1023-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01120J67: 6@22, Exp. 04/12/2016; Lot #: 021820J6 : 52@39, Exp.04/18/2016; Lot #: 02262016: 89@3, Exp. 04/26/2016; Lot #: 03082016 : 76@46 06/06/2016;03022016:61@8, Exp. 06/08/2016; 032120 16:49@65, Exp.06/21/2016; 01152016:48@14, Exp. 04/19/2016; 03032016:74@52, Exp. 05/02/2016; 03242016:68@13, Exp. 06/27/2016; 04142016:00@50, Exp. 06/13/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1005-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1005-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01252016:44@43, Exp. 07/26/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1002-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1002-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01262016:86@2, Exp. 07/30/2016; 02222016:31@27, Exp. 08/20/2016; Lot #: 03022016:1@47, Exp. 08/29/2016; Lot #: 03032016:26@ 1, Exp. 08/30/2016; Lot #: 04122016: 84@227, Exp.10/15/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0985-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0985-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01182016:29@27 , Exp. 02/01/2016; Lot #: 030720 1631@50, Exp. 03/21/2016; Lot #: 03232016:83@6, Exp 04/06/2016; Lot #: 03282016:43@11, Exp. 04/11/2016; Lot #: 04192016:43@16, Exp. 05/03/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0978-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0978-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 units (total all products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 04262016: 87@3, Exp. 07/26/2016; Lot #: 03102016:72@38 , Exp. 06/08/2016; Lot #: 12222015:88@23, Exp. 03/22/2016; Lot #: 02022016:73@27, Exp. 05/03/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1007-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1007-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02172016:86@12, Exp.05/18/2016; Lot #: 04012016:22@4, Exp.06/30/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0990-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0990-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 03012016:82@33, Exp. 05/30/2016; Lot #: 03012016:65@41, Exp. 06/16/2016; Lot #: 04142016:89@48, Exp. 07/12/2016; Lot #: 04142016: 28@49, Exp. 07/17/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1021-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1021-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01072016:16@30, Exp. 04/06/2016; Lot #: 01132016 : 34@42, Exp. 04/12/2016; Lot #: 03082016:02@13, Exp. 06/06/2016; Lot #: 03302016: 46@39, Exp. 06/30/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0996-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0996-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 03222016:11@22, Exp. 09/20/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1028-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1028-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 916 total units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02102016:22@57, Exp. 08/08/2016; Lot #: 02292016:59@55 ,Exp. 08/28/2016; Lot #: 03072016:68@7, Exp. 09/03/2016; Lot #: 4052016:41@56, Exp. 10/04/2016; Lot #: 04192016:41@34, Exp.10/16/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1008-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1008-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02052016:96@38, Exp.05/09/2016; Lot #: 04052016: 39@6, Exp. 07/04/2016; Lot #: 04132016:79@19, Lot #: 07/13/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1014-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1014-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02172016:12@37, Exp. 05/18/2016; Lot #: 03182016: 88@13, Exp. 06/16/2016; Lot #: 04202016:35@14, Exp. 07/19/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1026-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1026-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 916 total Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #:01082016:75@3, Exp.07/06/2016; Lot #:01282016:72@10, Exp. 07/27/2016; Lot #: 02012016:74@35, Exp. 07/31/2016; Lot #:02102016:40@16, Exp.08/09/2016; Lot #: 02242016:73@41, Exp. 08/23/2016; Lot #: 03102016:64@53, Exp.09/07/2016; Lot #:04052016:70@16 Exp. 10/02/2016; Lot #: 04222016:85@37, Exp.10/22/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0991-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0991-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01222016:81@52, Exp. 03/25/2016; Lot #:03042016: 23@29, Exp.05/22/2016; Lot #:03212016:35@53, Exp. 05/22/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1012-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1012-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02032016: 60@27, Exp. 05/03/2016; Lot #: 02222016: 29@62, Exp. 05/22/2016; Lot #: 03072016:87@66, Exp.06/06/2016; Lot #: 4152016:34@39, Exp. 07/18/2016; Lot #: 04282016:06@14, Exp. 07/27/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0999-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0999-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02022016 : 72@19, Exp. 07/13/2016; Lot #: 02092016: 09@23, Exp. 08/08/2016; Lot #: 02262016:14@7, Exp. 08/27/2016; Lot #:03022016: 60@23, Exp. 08/21/2016; Lot #: 03012016:54@20, Exp.08/24/2016; Lot #: 03212016: 35@49, Exp. 09/17/2016; Lot #: 04142016: 15@2, Exp. 10/11/2016; Lot #: 04212016: 69@19, Exp.10/19/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1016-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1016-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02292016:67@10, Exp. 05/29/2016; Lot #: 03022016: 98@43, Exp.05/31/2016; Lot #: 03162016:25@32, Exp. 06/14/2016; Lot #: 03302016:36@36, Exp.06/30/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1004-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1004-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01282016:60@3, Exp.04/28/2016; Lot #: 02242016: 90@20, Exp.05/24/2016; Lot #: 02222016:06@67, Exp. 05/24/2016; Lot #: 03082016:81@21, Exp.06/06/2016; Lot #: 03162016: 62@1, Exp. 06/14/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1025-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1025-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 011520J6:90@35, Exp.04/17/2016; Lot #: 04282016:23@31, Exp.08/01/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1027-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1027-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 916 total units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01042016:74@36, Exp. 07/03/2016; Lot #: 01052016:14@12, Exp.06/18/2016; Lot #: 01272016:70@17, Exp. 07/25/2016; Lot #:02222016:62@12, Exp.08/24/2016; Lot #:03212016:57@30, Exp. 09/17/2016; Lot #: 04182016:42@44, Exp.10/16/2016; Lot #:05012016:18@29, Exp.11/01/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1001-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1001-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01262016:77@53, Exp. 04/25/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0992-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0992-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 03142016:25@14, Exp. 04/15/2016; Lot #: 04182016: 22@14, Exp. 05/18/2016; Lot #: 04182016: 67@16, Exp. 05/19/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0997-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0997-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01182016:46@7, Exp.04/17/2016; Lot #: 02192016 60@29, Exp. 05/19/2016; Lot #: 04082016:83@53; Exp. 07/11/2016; Lot #: 04202016:61@66, Exp.07/19/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1011-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1011-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02042016: 80@58, Exp.05/04/2016; Lot #: 02222016:88@11, Exp.05/23/2016; Lot #: 03282016:42@5, Exp. 06/26/2016; Lot #: 03292016:29@1, Exp.06/27/2016; Lot #: 03222016:22@19, Exp. 06/28/2016; Lot #: 04202016:46@30, Exp.07/19/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0986-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0986-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016; Lot #: 01132016:18@44, Exp. 02/03/2016; Lot #: 01132016:74 @17, Exp. 03/04/2016; Lot #: 01132016:90@9, Exp. 03/04/2016; Lot #: 02222016:34@23, Exp. 04/03/2016; Lot #: 04282016:79@45, Exp. 06/27/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0993-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0993-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01272016:54@25, Exp.02/27/2016; Lot #: 03292016: 62@36 , Exp.04/29/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0987-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0987-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02232016: 64@43, Exp. 05/24/2016; Lot #: 03142016: 70@16,Exp. 06/14/2016; Lot #: 04182016:17@15, Exp.07/17/2016; Lot #: 04182016:64@12, Exp. 07/18/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0994-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0994-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2016; Lot #: 01272016:81@30, Exp.07/25/2016; Lot #: 02102016:89@2, Exp. 08/08/2016; 02162016:25@57, Exp.08/14/2016; 02262016:33@54, Exp.08/24/2016; Lot #: 03092016:64@51, Exp.09/07/2016; Lot #: 04142016:01@45, Exp.10/11/2016 04142016:17@37, Exp.10/15/2016; 04282016:72@48, Exp.10/29/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0982-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0982-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02022016:85@22 , Exp.05/03/2016; Lot #: 02242016:50@16, Exp. 06/12/2016; Lot #:03102016:30@65, Exp. 06/12/2016; Lot #: 3172016:14@19, Exp. 06/15/2016; Lot #: 04122016:20@2 , Exp. 07/11/2016; Lot #: 04212016:84@1, Exp. 07/20/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1018-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1018-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 02162016:54@17, Exp. 05/17/2016; Lot #: 03232016: 19@8, Exp. 06/20/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1013-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1013-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 01042016:26@3, Exp.04/03/2016; Lot #: 01072016: 10@15, Exp.04/06/2016; Lot #: 02032016:41@16, Exp. 05/03/2016; Lot #: 03152016: 62@44, Exp.06/15/2016; Lot #: 04292016:35@11, Exp. 07/31/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1020-2016
- Event ID
- 74187 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1020-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- NV What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Reason For Recall
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 869 Units (Total All Products) Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-15-2016
- Recall Initiation Date
- 05-17-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Well Care Compounding Pharmacy
- Code Info
- Lot #: 12302015:53@18, Exp.04/29/2016; Lot #: 03142016:67@53, Exp. 06/12/2016; Lot #: 03302016: 43@38, Exp. 06/28/2016; Lot #: 03/292016: 30@23, Exp. 06/29/2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
