The Recall Desk
ModerateFDA (Drugs)·D-1071-2019·Announced 2019-04-10

Pfizer Recalls Clindamycin Injection Due to Impurity Specification Failures

Pfizer is recalling specific lots of Clindamycin Injection because high out-of-specification impurities were found 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 FDA classified this recall as Class III, which is defined as unlikely to cause adverse health consequences. Per the rubric, Class III recalls are typically scored as 1 or 2; a score of 2 is assigned here to reflect the nature of the chemical impurity failure, which is a quality deviation rather than a cosmetic or packaging-only issue.

Plain-English summary

Pfizer Inc. is recalling 8,878 cartons of Clindamycin Injection, USP, 600 mg/4 mL (150 mg/mL), 4 mL vials. The product is distributed by Alvogen, Inc., and was available nationwide in the USA and in Guam. The recall involves 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 established impurities and degradation specifications.

Healthcare providers and patients should stop using the affected lots of Clindamycin Injection and contact their pharmacist or healthcare provider for guidance on alternative treatments. The FDA has classified this recall as Class III, which is the lowest risk classification, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

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
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 (7)

  • Lot #: T97496
  • Exp.04/2019
  • T97497
  • Exp.07/2019
  • W28564(exp 09/2019)
  • W31812
  • 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

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