FDA Recall D-1398-2019
Heritage Pharmaceuticals, Inc. · East Brunswick, NJ
Class I — life-threatening Terminated 966 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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) .
Recall record
- Recall number
D-1398-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2019-05-21
- Classified by FDA Center
- 2019-06-19
- FDA published
- 2019-06-19
- Terminated
- 2022-01-11
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Firm location
- East Brunswick, NJ
Drug identification
- Brand name(s)
- AMIKACIN SULFATE
- Generic name(s)
- AMIKACIN SULFATE
- Manufacturer(s)
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC(s)
23155-290- Route(s)
- INTRAMUSCULAR, INTRAVENOUS