Clindamycin Injection recall: Impurity Out of Spec
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
Why was Clindamycin Injection recalled?
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: T96398, Exp.07/2019, T97492, Exp.04/2019, W28567, Exp. 09/2019, W31813, Exp.10/2019
- Product
- Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
- Recalling firm
- Pfizer Inc.
- Quantity
- 8,320 cartons (25 vials per carton)
- Distribution
- Nationwide USA and Guam
- Recall date
- April 10, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)