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- Recall Enforcement Event ID: 82754
Recall Enforment Report D-1297-2019
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Unipharma, Llc., originally initiated on 05-02-2019 for the product CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675 The product was recalled due to cgmp deviations: recall as a precautionary measure due to potential risk of product contamination with the bacteria b. cepacia.. The product was distributed nationwide 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-1297-2019 | 05-02-2019 | 05-22-2019 | Class II | 33360 cartons | CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1305-2019 | 05-02-2019 | 05-22-2019 | Class II | 816 cartons | DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1296-2019 | 05-02-2019 | 05-22-2019 | Class II | 15264 cartons | CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1304-2019 | 05-02-2019 | 05-22-2019 | Class II | 23712 cartons | CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1302-2019 | 05-02-2019 | 05-22-2019 | Class II | 38640 cartons | CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1303-2019 | 05-02-2019 | 05-22-2019 | Class II | 39216 cartons | DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1299-2019 | 05-02-2019 | 05-22-2019 | Class II | 280 cartons | DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1301-2019 | 05-02-2019 | 05-22-2019 | Class II | 1344 cartons | DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1298-2019 | 05-02-2019 | 05-22-2019 | Class II | 1060 cartons | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1306-2019 | 05-02-2019 | 05-22-2019 | Class II | 21456 cartons | CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
| D-1300-2019 | 05-02-2019 | 05-22-2019 | Class II | 27840 cartons | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Terminated |
Recall Enforcement Report D-1297-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1297-2019 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
- Nationwide and Venezuela 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
- CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 33360 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: 80053; 80055 Exp. 10/31/20 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-1305-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1305-2019 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
- Nationwide and Venezuela 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
- DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 816 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: a) 90002 Exp. 01/31/21; b) 90008 Exp. 02/28/21 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-1296-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1296-2019 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
- Nationwide and Venezuela 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
- CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 15264 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lot: 80061 Exp. 11/30/20 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-1304-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1304-2019 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
- Nationwide and Venezuela 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
- CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 23712 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: 80026 Exp. 05/31/20; 80027 Exp. 07/31/20 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-1302-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1302-2019 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
- Nationwide and Venezuela 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
- CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 38640 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: 80043 Exp. 07/05/20; 80047 Exp. 07/31/20 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-1303-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1303-2019 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
- Nationwide and Venezuela 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
- DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 39216 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lot: 80062 Exp. 11/30/20 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-1299-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1299-2019 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
- Nationwide and Venezuela 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
- DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 280 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: 80061 Exp. 11/30/20 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-1301-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1301-2019 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
- Nationwide and Venezuela 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
- DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1344 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lot: 80054 Exp. 10/31/20 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-1298-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1298-2019 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
- Nationwide and Venezuela 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
- DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1060 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: 80058; 80060, Exp. 11/30/20 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-1306-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1306-2019 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
- Nationwide and Venezuela 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
- CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 21456 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: 80054; 80056 Exp. 10/31/20 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-1300-2019
- Event ID
- 82754 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1300-2019 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
- Nationwide and Venezuela 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
- CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156
- Reason For Recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 27840 cartons 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
- 05-22-2019
- Recall Initiation Date
- 05-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-25-2020 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter 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
- Unipharma, Llc.
- Code Info
- Lots: 80058; 80059 Exp. 11/30/20 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.
