Home / Recalls / West-Ward Pharmaceuticals Corp. / D-1515-2016

D-1515-2016 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
September 28, 2016
Initiation Date
August 18, 2016
Termination Date
September 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)

Product Description

Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

Reason for Recall

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

Distribution Pattern

Nationwide

Code Information

Lot #: AS1413A, AS1414A; Exp. 11/18

Other recalls by West-Ward Pharmaceuticals Corp.

  • D-0094-2018 Class III — Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (November 6, 2017)
  • 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)