March 2023 FDA Recall Drug by Accord Healthcare, Inc.
D-0528-2023 - Sub-potent drug
This Class III drug recall was voluntarily initiated by Accord Healthcare, Inc. on March 29, 2023 for the product Drug. The FDA reported the reason for recall as sub-potent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0528-2023
Sub-potent drug: assay test result below specifications at 9-month timepoint.
03-29-2023
04-12-2023
4574 cartons
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.
Accord Healthcare, 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
03-19-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.
Batch or Lot Expiration Information
Lot# : R2200394 Exp. 03/2024
