FDA-Drug2019-04-10Class III

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

Pfizer Inc.
Hazard

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Sold states
Nationwide USA and Guam
Affected count
8,320 cartons (25 vials per carton)
Manufactured in
235 E 42nd St, N/A, New York, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1072-2019

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