Reported Apr 20, 2022 · Terminated
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for…
Aurobindo Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- 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.
- Lot codes and dates
- Lots
CCC210004Exp 09/2022CCC210005CCC210006CCC210007Exp 11/2022CCC210010CCC210011Exp 04/2023
- Lots
- Amount recalled
- 433,809 vials
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Out of Specification results for Assay
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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