Drug product
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
D-1454-2016
Product summary
- Event
- Event 74832
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,331 vials
- Official record key
drug-enforcement:D-1454-2016
Official wording
Reason: Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Code information: Lot# 03037, Exp 8/17/16; 03042, 03043, Exp 8/31/16; 04043, Exp 9/29/16; 04047, 04048, Exp 10/1/16; 04052, 04053, Exp10/2/16; 05042, Exp 10/29/16; 05046, Exp 11/2/16; 05048, 05049, Exp 11/3/16; 05050 Exp 11/4/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
Lack of processing controls