April 2022 FDA Recall Drug by American Health Packaging
D-0790-2022 - Subpotent Drug

This Class III drug recall was voluntarily initiated by American Health Packaging on April 12, 2022 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in Alabama and the recall is currently terminated.

Recall Number: D-0790-2022

Reason for Recall
Subpotent Drug: Out of specification for assay.
Initiated
04-12-2022
Reported
05-04-2022
Quantity
97,975 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90003
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Alabama
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2022
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59

Batch or Lot Expiration Information

Lot# Lots: CCC210008, CCC210009, Exp. 01/23