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Recall Observatory FDA recall evidence

Drug product

Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.

D-0681-2017

April 06, 2017

Class II

Product summary

Firm
Isomeric Pharmacy Solution, LLC
Event
Event 76951
Status
Terminated
Classification
Class II
Quantity
4,001 vials
Official record key
drug-enforcement:D-0681-2017

Official wording

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information: Lot #s: 09007, Exp 04/04/17; 09016, Exp 04/16/17; 09020, Exp 04/18/17; 09025, Exp 04/23/17; 10026, 10030, Exp 05/28/17; 11007, Exp 05/30/17; 11008, Exp 05/31/17; 11020, Exp 06/07/17; 11028, Exp 06/12/17; 11043, Exp 06/26/17.

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility