Isomeric Pharmacy Solution, LLC recalls Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for inject…

Recall date

August 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1454-2016

FDA classification

Class II

Brand / firm

Isomeric Pharmacy Solution, LLC

Sold / distributed

Nationwide and Puerto Rico

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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