The Recall Desk
ModerateFDA (Drugs)·D-1072-2019·Announced 2019-04-10

Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

Pfizer is recalling specific lots of Clindamycin Injection due to high out-of-specification impurity results at the 24-month time point.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard involves impurity failures without reported illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Pfizer Inc. is recalling 8,320 cartons of Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vials. The product is distributed by Alvogen, Inc. and is available nationwide in the USA and Guam. The recall affects specific lots with expiration dates ranging from April 2019 to October 2019.

The recall was initiated because high out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point. This indicates that the product failed to meet required impurity and degradation specifications.

Healthcare providers and patients should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on alternative treatments. Consumers should check their medication vials for the specific lot numbers and expiration dates listed in the recall notice.

The recalled product

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
Manufacturer
Pfizer Inc.
Category
Drug — Antibiotic Injection
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #: T96398
  • Exp.07/2019
  • T97492
  • Exp.04/2019
  • W28567
  • Exp. 09/2019
  • W31813
  • Exp.10/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Pfizer Inc.

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Same hazard · impurity failure

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