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.
Reported: November 29, 2017 Initiated: November 6, 2017 #D-0093-2018
Product Description
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).
Details
- Recalling Firm
- West-Ward Pharmaceuticals Corp.
- Units Affected
- 16,157 shelf packs
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by West-Ward Pharmaceuticals Corp.. Units affected: 16,157 shelf packs.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 29, 2017. Severity: Low. Recall number: D-0093-2018.
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