Dexamethasone Sodium Phosphate Injection recall: Impurity Out of Spec
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.
Why was Dexamethasone Sodium Phosphate Injection recalled?
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 106352, Exp 10/18
- 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.
- Recalling firm
- West-Ward Pharmaceuticals Corp.
- Quantity
- 1,896 shelf packs
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- November 29, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)