FDA recall D-1070-2019

Product

Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94

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

Distribution

Nationwide USA and Guam

Key facts

Status

Terminated

Initiation date

2019-03-15

Report date

2019-04-10

Termination date

2022-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1070-2019