Recalls / Class II

Class IID-0682-2017

Product

Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.

Affected lot / code info

Lot #s: 09022, Exp 04/22/17; 10001, Exp 05/02/17; 11001, Exp 05/31/17; 11010, Exp 06/03/17; 11037, Exp 06/19/17; 11041, Exp 06/25/17.

Why it was recalled

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

Recalling firm

Firm

Isomeric Pharmacy Solution, LLC

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

2401 S Foothill Dr Ste D, N/A, Salt Lake City, Utah 84109-1479

Distribution

Quantity

2,352 vials

Distribution pattern

Nationwide in the USA and Puerto Rico

Timeline

Recall initiated

2017-04-06

FDA classified

2017-04-26

Posted by FDA

2017-05-03

Terminated

2017-08-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0682-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.