FDA Recall D-1216-2022

TMC Acquisition LLC dba Tailor Made Compounding · Nicholasville, KY

Class II Ongoing 1529 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

Lot / code: 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: 191 vials

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-1216-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA and Puerto Rico
Recall initiated: 2022-03-07
Classified by FDA Center: 2022-07-14
FDA published: 2022-07-20
Recalling firm: TMC Acquisition LLC dba Tailor Made Compounding
Firm location: Nicholasville, KY

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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