FDA Drug recall D-1068-2019
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division…
- FDA Drug
- Class III
- terminated
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class III recall of Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division… by Pfizer, citing failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1068-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-15 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Identifiers
| ndc | 0009-0870-21 |
|---|---|
| ndc | 0009-0870-26 |
| ndc | 0009-0775-20 |
| ndc | 0009-0775-26 |
| ndc | 0009-0902-11 |
| ndc | 0009-0902-18 |
| ndc | 0009-0728-05 |
| ndc | 0009-0728-09 |
| ndc | 0009-3124-01 |
| ndc | 0009-3124-03 |
| ndc | 0009-3447-01 |
| ndc | 0009-3447-03 |
| ndc | 0009-3381-01 |
| ndc | 0009-3381-02 |
| ndc | 0009-3375-01 |
| ndc | 0009-3375-02 |
| ndc | 0009-3382-01 |
| ndc | 0009-3382-02 |
| ndc | 0009-6582-02 |
| ndc | 0009-6582-01 |
| code_info | Lot#: T78191, Exp.04/2019, T97494, Exp.07/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1068-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.