West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5…

Recall date

November 6, 2017

Source

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

Recall number

D-0094-2018

FDA classification

Class III

Brand / firm

West-Ward Pharmaceuticals Corp.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.