Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Summary
The FDA issued a Class II for Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor by TMC Acquisition LLC dba Tailor Made Compounding. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-1216-2022
Action Date
2022-07-20
Status
Ongoing
Category
drug
Product Description
Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Lot/Code Info: Batch #: a) 10282106A1, Exp 4/26/2022; 11022118A1, Exp 4/30/2022; 12292115A1, Exp 6/27/2022; b)12082113A2, Exp 6/2/2022; 12292115A1, Exp 6/27/2022; 03072230A1, Exp 9/3/2022.
Quantity Affected: 191 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-07
Company
Nicholasville, KY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
TMC Acquisition LLC dba Tailor Made Compounding has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (TMC Acquisition LLC dba Tailor Made Compounding) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TMC Acquisition LLC dba Tailor Made Compounding have FDA actions?
TMC Acquisition LLC dba Tailor Made Compounding has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1216-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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