Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Reported: April 20, 2022 Initiated: April 5, 2022 #D-0766-2022
Product Description
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Reason for Recall
Subpotent Drug: Out of Specification results for Assay
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 433,809 vials
- Distribution
- Nationwide in the USA.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.. Recalled by Aurobindo Pharma USA Inc.. Units affected: 433,809 vials.
Why was this product recalled? ▼
Subpotent Drug: Out of Specification results for Assay
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 20, 2022. Severity: Low. Recall number: D-0766-2022.
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