Drug recall D-1398-2019
Product
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
Reason for recall
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Lots and codes
Lot: VEAC025, EXP 10-2019
Recall details
- Recalling firm
- Heritage Pharmaceuticals, Inc., East Brunswick, NJ
- Quantity
- 14,960 4 mL vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 21, 2019
- Terminated
- January 11, 2022
Related products
- Amikacin Sulfate – drug information
- NDC 23155-290 Amikacin Sulfate · Amikacin Sulfate 250 mg/mL · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.