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

FDA recall notice · announced August 10, 2016 · Isomeric Pharmacy Solution

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/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
Quantity: 2,331 vials
Status: Terminated
Products in this recall event:
- 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 8 (D-1454-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.