Class II · Moderate risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Enalapril Maleate Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
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
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61.
Affected NDC
0904-5502-61
Compare with the code on your package — it is the most precise check available.
Drug: Enalapril Category: Blood Pressure Medication
- Recalling firm
- Major Pharmaceuticals
- NDC code
- 0904-5502-61
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0980-2018 · 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 Enalapril recalls
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