April 2022 FDA Recall Cyanocobalamin by Aurobindo Pharma Usa Inc.
D-0766-2022 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on April 5, 2022 for the product Cyanocobalamin. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0766-2022
Subpotent Drug: Out of Specification results for Assay
04-05-2022
04-20-2022
433,809 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
06-27-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
