Class III · Low risk
Methadone Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Ethacrynic Acid Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
0054-0415-25
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- West-Ward Columbus Inc
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1282-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by West-Ward Columbus Inc
All 2020 recalls
Class III · Low risk
Methotrexate Tablets
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class II · Moderate risk
Doxycycline Hyclate Tablets USP
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Other impurity / degradation recalls from 2020
All impurity / degradation recalls
Class III · Low risk
Benzhydrocodone and Acetaminophen Tablets
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Hydroxyzine Hydrochloride Oral Solution
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
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