Drug 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
D-1398-2019
Product summary
- Event
- Event 82918
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,960 4 mL vials
- Official record key
drug-enforcement:D-1398-2019
Official wording
Reason: 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) .
Code information: Lot: VEAC025, EXP 10-2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial growth