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.
What this means for you
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
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 brand · CLEOCIN PHOSPHATE
- ModeratePfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
FDA (Drugs) · 2019-04-10
- LowPfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
FDA (Drugs) · 2019-04-10
- SeverePharmacia Recalls Cleocin Phosphate Vials Due to Glass Delamination
FDA (Drugs) · 2013-06-26
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