Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 106352, Exp 10/18
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0094-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 6, 2017
- FDA report date
- Nov 29, 2017
- Quantity
- 1,896 shelf packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-0094-2018, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78415
- Address
- 401 Industrial Way West
- Code information
- Lot #: 106352, Exp 10/18
- Postal code
- 07724-2209
- Report date
- Nov 29, 2017
- Product type
- Drugs
- Recall number
- D-0094-2018
- Classification
- Class III
- Recalling firm
- West-Ward Pharmaceuticals Corp.
- Product quantity
- 1,896 shelf packs
- Termination date
- Apr 1, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Nov 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2017