Drug 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
D-0518-2017
Product summary
- Event
- Event 76676
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,999 single-use vials
- Official record key
drug-enforcement:D-0518-2017
Official wording
Reason: CGMP Deviations
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations