The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1067-2019·Announced 2019-04-10

Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurities were detected 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Pfizer Inc. is recalling 67 cartons (25 vials per carton) of Cleocin Phosphate (clindamycin injection), USP, 300 mg/2 mL (150 mg/mL), 2 mL-vial, Rx only. The affected lots are T97469 (Exp. 7/2019) and W28574 (Exp. 09/2019). The product was distributed nationwide in the USA and in Guam.

The recall was initiated because high out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point. This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected lots and contact Pfizer or their supplier for instructions on return or replacement. Consumers should not use the product if they have the specific lot numbers and expiration dates listed above.

The recalled product

Product
CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
Brand
CLEOCIN PHOSPHATE
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 (4)

  • Lot #: T97469
  • Exp. 7/2019
  • W28574
  • Exp.09/2019

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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Same hazard · impurity

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