Multi-event March 2019 FDA Recall Cleocin Phosphate by Pfizer Inc.
This Multi-event Class III drug recall was voluntarily initiated by Pfizer Inc. on March 15, 2019 for the product Cleocin Phosphate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1072-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
03-15-2019
04-10-2019
8,320 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Guam
08-11-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
Batch or Lot Expiration Information
Lot# : T96398, Exp.07/2019, T97492, Exp.04/2019, W28567, Exp. 09/2019, W31813, Exp.10/2019
Recall Number: D-1071-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
03-15-2019
04-10-2019
8,878 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Guam
08-11-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
Batch or Lot Expiration Information
Lot# : T97496, Exp.04/2019, T97497, Exp.07/2019, W28564(exp 09/2019), W31812, Exp. 10/2019.
Recall Number: D-1070-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
03-15-2019
04-10-2019
701 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Guam
08-11-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
Batch or Lot Expiration Information
Lot# Lot: T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), W31814 (exp 10/2019)
Recall Number: D-1067-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
03-15-2019
04-10-2019
67 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Guam
08-11-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02
Batch or Lot Expiration Information
Lot# : T97469, Exp. 7/2019, W28574, Exp.09/2019
Affected Packages Involved in this Recall
Recall Number: D-1069-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
03-15-2019
04-10-2019
500 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Guam
08-11-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01
Batch or Lot Expiration Information
Lot# : T78193, Exp.04/2019
Affected Packages Involved in this Recall
Recall Number: D-1068-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
03-15-2019
04-10-2019
820 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Guam
08-11-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01
Batch or Lot Expiration Information
Lot# : T78191, Exp.04/2019, T97494, Exp.07/2019
