Recalls / Class II
Class IID-1454-2016
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
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- Isomeric Pharmacy Solution, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2401 S Foothill Dr, Salt Lake City, Utah 84109-1479
Distribution
- Quantity
- 2,331 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-08-01
- FDA classified
- 2016-08-04
- Posted by FDA
- 2016-08-10
- Terminated
- 2017-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1454-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.