Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for A
Summary
The FDA issued a Class III for Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Via by Aurobindo Pharma USA Inc.. Reason: Subpotent Drug: Out of Specification results for Assay.
Details
Source
Drug Recall
External ID
D-0766-2022
Action Date
2022-04-20
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
Quantity Affected: 433,809 vials
Reason for Recall
Subpotent Drug: Out of Specification results for Assay
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-05
Company
East Windsor, NJ
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 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 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 (Aurobindo Pharma USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurobindo Pharma USA Inc. have FDA actions?
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0766-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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