Recalls / Class II
Class IID-0684-2017
Product
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
- Affected lot / code info
- Lot #s: 10013, Exp 05/10/17; 10020, Exp 05/20/17; 10029, Exp 05/27/17; 11002, Exp 05/30/17; 11013, Exp 06/04/17.
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
- 1,951 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-0684-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.