Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
Pfizer is recalling specific lots of Cleocin Phosphate 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 a direct, immediate safety hazard like contamination or mislabeling of a critical allergen.
Plain-English summary
Pfizer Inc. is recalling 500 cartons of Cleocin Phosphate (clindamycin phosphate) injection, USP, 900 mg/6 mL (150 mg/mL). The affected product is identified by Lot # T78193 with an expiration date of 04/2019. The product is 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 indicates that the product failed to meet the required impurities/degradation specifications.
Healthcare providers and pharmacies should discontinue use of the affected lots and contact Pfizer for further instructions. Patients who have received this medication should consult their healthcare provider if they have concerns.
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 (2)
- Lot #: T78193
- Exp.04/2019
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
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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
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