Cleocin Phosphate — Class III drug recall D-1068-2019
Terminated recall by Pfizer Inc., reported 2019-04-10, distributed nationwide. Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for se
| Recall number | D-1068-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2019-03-15 |
| Classified | 2019-03-29 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2022-08-11 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00009-0728, 00009-0728-05, 00009-0728-09, 00009-0775, 00009-0775-20, 00009-0775-26, 00009-0870, 00009-0870-21, 00009-0870-26, 00009-0902, 00009-0902-11, 00009-0902-18, 00009-3124, 00009-3124-01, 00009-3124-03, 00009-3375, 00009-3375-01, 00009-3375-02, 00009-3381, 00009-3381-01, 00009-3381-02, 00009-3382, 00009-3382-01, 00009-3382-02, 00009-3447 and 5 more |
| Lot numbers | T78191, T97494 |
| Expiration dates | 2019-04, 2019-07 |
Product
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01
Reason for recall
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1068-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.