The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1070-2019·Announced 2019-04-10

Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

Pfizer is recalling specific lots of Clindamycin Injection because high levels of impurities were found at the 24-month time point.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue involves impurity specifications rather than an acute safety hazard like contamination or mislabeling of a critical allergen.

Plain-English summary

Pfizer Inc. is recalling specific lots of Clindamycin Injection, USP, 300 mg/2 mL (150 mg/mL), 2 mL vials. The affected product is distributed by Alvogen, Inc. and is available nationwide in the USA and Guam. The recall involves 701 cartons, with 25 vials per carton.

The recall was initiated because high out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point. The affected lots are T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), and W31814 (exp 10/2019).

Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

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
Manufacturer
Pfizer Inc.
Category
Drug — Injectable Antibiotic
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 (4)

  • Lot: T97472 (exp 07/2019)
  • T97473 (exp 04/2019)
  • W28573 (exp 09/2019)
  • W31814 (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 →

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