Recalls / Class I
Class ID-1398-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Amikacin Sulfate
- Generic name
- Amikacin Sulfate
- Active ingredient
- Amikacin Sulfate
- Route
- Intramuscular, Intravenous
- NDC
- 23155-290
- FDA application
- ANDA204040
- Affected lot / code info
- Lot: VEAC025, EXP 10-2019
Why it was recalled
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) .
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 14,960 4 mL vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-21
- FDA classified
- 2019-06-19
- Posted by FDA
- 2019-06-19
- Terminated
- 2022-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1398-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.