FDAFDA · Food and drugs·Recall number D-1454-2016
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
Published August 10, 2016 · Recall initiated: August 1, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Isomeric Pharmacy Solution, LLC
- Distributor
- Nationwide and Puerto Rico
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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