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
Reported: June 19, 2019 Initiated: May 21, 2019 #D-1398-2019
Product Description
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) .
Details
- Recalling Firm
- Heritage Pharmaceuticals, Inc.
- Units Affected
- 14,960 4 mL vials
- Distribution
- Nationwide in the USA
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Heritage Pharmaceuticals, Inc.. Units affected: 14,960 4 mL vials.
Why was this product 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) .
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2019. Severity: Critical. Recall number: D-1398-2019.
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