Recalls / Class III
Class IIID-0093-2018
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.
- Brand name
- Dexamethasone Sodium Phosphate
- Generic name
- Dexamethasone Sodium Phosphate
- Active ingredient
- Dexamethasone Sodium Phosphate
- Route
- Intramuscular, Intravenous
- NDCs
- 0641-0367, 0641-6145, 0641-6146
- FDA application
- ANDA087702
- Affected lot / code info
- Lot #: 106390, 106393, 106395, Exp 10/18
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Recalling firm
- Firm
- West-Ward Pharmaceuticals Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 401 Industrial Way West, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 16,157 shelf packs
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-11-06
- FDA classified
- 2017-11-22
- Posted by FDA
- 2017-11-29
- Terminated
- 2020-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0093-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.