Recall: D-0766-2022

Class III - Minor Violations

Class IIIClassification

2022-04-05Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

Product

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

Subpotent Drug: Out of Specification results for Assay

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.