Recall: D-0094-2018

Class III - Minor Violations

Class IIIClassification

2017-11-06Initiated

TerminatedStatus

West-Ward Pharmaceuticals CorpFirm

Product

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.

Reason

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

Distribution

Nationwide in the USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.