Home / Recalls / West-Ward Pharmaceuticals Corp. / D-0094-2018

D-0094-2018 Class III Terminated

Recalled by West-Ward Pharmaceuticals Corp. — Eatontown, NJ

Recall Details

Product Type
Drugs
Report Date
November 29, 2017
Initiation Date
November 6, 2017
Termination Date
April 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,896 shelf packs

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #: 106352, Exp 10/18

Other recalls by West-Ward Pharmaceuticals Corp.

  • D-0093-2018 Class III — Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-614 (November 6, 2017)
  • D-0172-2017 Class III — SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, (November 17, 2016)
  • D-0147-2017 Class III — Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), R (November 4, 2016)
  • D-1045-2017 Class II — Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward P (October 3, 2016)
  • D-1515-2016 Class III — Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when recon (August 18, 2016)