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- Recall Enforcement Event ID: 75650
Recall Enforment Report D-0467-2017
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by VistaPharm, Inc., originally initiated on 01-18-2017 for the product Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16. The product was recalled due to cgmp deviations: purified water used to manufacture the drug products may have been contaminated with burkholderia 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-0467-2017 | 01-18-2017 | 02-08-2017 | Class II | 3,354 bottles | Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0459-2017 | 01-18-2017 | 02-08-2017 | Class II | 3,496 unit dose cups | Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0461-2017 | 01-18-2017 | 02-08-2017 | Class II | 55,191 unit dose cups | Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0458-2017 | 01-18-2017 | 02-08-2017 | Class II | 32,027 bottles and 16,310 unit dose cups | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0457-2017 | 01-18-2017 | 02-08-2017 | Class II | 67,955 bottles | Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0466-2017 | 01-18-2017 | 02-08-2017 | Class II | 14,368 bottles | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0463-2017 | 01-18-2017 | 02-08-2017 | Class II | 7,404 unit dose cups | Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0462-2017 | 01-18-2017 | 02-08-2017 | Class II | 18,437 unit dose cups | Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0460-2017 | 01-18-2017 | 02-08-2017 | Class II | 12,059 unit dose cups | Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0464-2017 | 01-18-2017 | 02-08-2017 | Class II | 42,776 unit dose cups and 17,403 bottles | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
| D-0465-2017 | 01-18-2017 | 02-08-2017 | Class II | 127,193 bottles | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | Terminated |
Recalled Products
| NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
|---|---|---|---|---|---|---|
| 66689-036 | Phenytoin | Vistapharm, Llc | ||||
| 66689-694 | Methadone Hydrochloride | Methadone Hydrochloride | Concentrate | Oral | Vistapharm, Llc | Human Prescription Drug |
| 66689-695 | Methadone Hydrochloride | Methadone Hydrochloride | Concentrate | Oral | Vistapharm, Llc | Human Prescription Drug |
| 66689-711 | Methadone Hydrochloride | Methadone Hydrochloride | Solution | Oral | Vistapharm, Llc | Human Prescription Drug |
| 66689-712 | Methadone Hydrochloride | Methadone Hydrochloride | Solution | Oral | Vistapharm, Llc | Human Prescription Drug |
| 66689-775 | Phenytoin | Phenytoin | Suspension | Oral | Vistapharm, Llc | Human Prescription Drug |
Recall Enforcement Report D-0467-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0467-2017 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 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
- Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,354 bottles 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- Lot No. 388700 (Exp. 01/17) 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
- 66689-711-16; 66689-712-16
- 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-0459-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0459-2017 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 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
- Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,496 unit dose cups 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- Lot No. 428700 (Exp. 11/17), 409500 (Exp.06/17) 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-0461-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0461-2017 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 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
- Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 55,191 unit dose cups 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- a). Lot No. 428900, 425600 (Exp. 05/17); 421200 (Exp. 04/17), 413600 (Exp. 02/17), 411500 (Exp. 01/17), 417200 (Exp. 03/17) b). Lot No. 429300 (Exp. 06/17) ,426500 (Exp. 05/17), 420600 (Exp. 03/17), 417000 (Exp.03/17), 412900 (Exp. 01/17), 409900 (Exp. 01/17) 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-0458-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0458-2017 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 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
- Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 32,027 bottles and 16,310 unit dose cups 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17) 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-0457-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0457-2017 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 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
- Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 67,955 bottles 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18) 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-0466-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0466-2017 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 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
- Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 14,368 bottles 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17) 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
- 66689-694-30; 66689-694-79; 66689-694-88; 66689-695-79
- 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-0463-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0463-2017 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 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
- Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,404 unit dose cups 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- a). Lot No. 728300 (Exp. 11/17), 423200 (Exp. 10/17), 418400 (Exp. 09/17), 411100 (Exp. 07/17), 406500 (Exp. 06/17) 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-0462-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0462-2017 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 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
- Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 18,437 unit dose cups 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- Lot No. 422800 (1Exp. 0/17), 430500 (Exp. 12/17), 424000 (Exp. 10/17), 412500 (Exp. 07/17), 405500 (Exp. 05/17), 414900 (Exp. 09/17) 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-0460-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0460-2017 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 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
- Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 12,059 unit dose cups 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- Lot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17) 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
- 66689-036-01; 66689-036-50; 66689-775-08
- 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-0464-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0464-2017 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 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
- Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 42,776 unit dose cups and 17,403 bottles 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- a). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17) 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-0465-2017
- Event ID
- 75650 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0465-2017 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 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
- Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
- Reason For Recall
- CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 127,193 bottles 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
- 02-08-2017
- Recall Initiation Date
- 01-18-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-26-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- VistaPharm, Inc.
- Code Info
- a). Lot No. 416600 (Exp. 09/17) b). Lot No.449100 , 447500 (Exp. 04/18), 421800 (Exp. 10/17), 418600 (Exp. 09/17), 408700 (Exp. 06/17), 411900 (Exp. 07/17), 413800 (Exp. 08/17), 416500 (Exp. 09/17), 408500 (Exp. 06/17), 389800 (Exp. 01/17), 429900 (Exp. 12/17), 406300, 406100 (Exp. 05/17), 429700 (Exp. 12/17), 427300, 427100, 425900 (11/17) 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
- 66689-694-30; 66689-694-79; 66689-694-88; 66689-695-79; 66689-695-30
- 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.
