Recalls / Class II

Class IID-0518-2017

Product

Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1

Affected lot / code info

Lot #08016; Exp. 03/14/17 Lot #08018; Exp. 03/15/17 Lot #08023; Exp. 03/22/17 Lot #08026; Exp. 03/19/17 Lot #08033; Exp. 03/28/17 Lot #09004; Exp. 04/03/17 Lot #11014; Exp. 06/10/17 Lot #11031; Exp. 06/20/17

Why it was recalled

CGMP Deviations

Recalling firm

Firm

Isomeric Pharmacy Solution, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

6,999 single-use vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2017-03-08

FDA classified

2017-03-13

Posted by FDA

2017-03-22

Terminated

2017-05-25

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0518-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.