Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.

FDA recall notice · announced November 29, 2017 · West-ward Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.

Reason for recall

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

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: 106390, 106393, 106395, Exp 10/18
Quantity: 16,157 shelf packs
Status: Terminated
Products in this recall event:
- 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, E (D-0094-2018)
- Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ (D-0093-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.