Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Ma
Summary
The FDA issued a Class III for Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneou by American Health Packaging. Reason: Subpotent Drug: Out of specification for assay..
Details
Source
Drug Recall
External ID
D-0790-2022
Action Date
2022-05-04
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lots: CCC210008, CCC210009, Exp. 01/23
Quantity Affected: 97,975 vials
Reason for Recall
Subpotent Drug: Out of specification for assay.
Distribution
Alabama
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-12
Company
Columbus, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 121 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
American Health Packaging has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Health Packaging) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Health Packaging have FDA actions?
American Health Packaging has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0790-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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