Recalls / Class III
Class IIID-1068-2019
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
- Brand name
- Cleocin Phosphate
- Generic name
- Clindamycin Phosphate
- Active ingredient
- Clindamycin Phosphate
- Route
- Intramuscular, Intravenous
- NDCs
- 0009-0728, 0009-0870, 0009-0775, 0009-0902, 0009-3124, 0009-3447, 0009-3381, 0009-3375, 0009-3382, 0009-6582
- FDA application
- NDA050441
- Affected lot / code info
- Lot#: T78191, Exp.04/2019, T97494, Exp.07/2019
Why it was recalled
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pharmacia & Upjohn Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 820 cartons (25 vials per carton)
- Distribution pattern
- Nationwide USA and Guam
Timeline
- Recall initiated
- 2019-03-15
- FDA classified
- 2019-03-29
- Posted by FDA
- 2019-04-10
- Terminated
- 2022-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1068-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.