Columbus, OH, United States
West-Ward Columbus Inc recalls
7 recalls recorded since 2018, most recently on 19 December 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)2
Terminated or completed5
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 19 December 2024
- Reason
- Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0183-2025
- Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Ongoing Class III Drugs
- Recall started
- 22 September 2023
- Reason
- Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
- Distribution
- MS, OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0066-2024
- Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
Terminated Class III Drugs
- Recall started
- 22 July 2020
- Terminated
- 12 August 2022
- Reason
- Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
- Distribution
- OH and MS
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1490-2020
- Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10
Terminated Class II Drugs
- Recall started
- 13 May 2020
- Terminated
- 25 March 2023
- Reason
- Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1274-2020
- Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
Terminated Class III Drugs
- Recall started
- 13 May 2020
- Terminated
- 2 October 2022
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1282-2020
- Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
Terminated Class II Drugs
- Recall started
- 9 September 2019
- Terminated
- 15 June 2022
- Reason
- Failed Impurities/Degradation Specificattion
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1863-2019
- Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
Terminated Class II Drugs
- Recall started
- 24 July 2018
- Terminated
- 29 April 2020
- Reason
- Failed Dissolution Specifications:
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1025-2018, D-1024-2018
- Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
- Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.