The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0980-2018·Announced 2018-08-01

Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, 5 mg, due to out-of-specification degradation products.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton. The product is distributed nationwide in the USA and Puerto Rico. The recall is a sub-recall initiated because the manufacturing firm, Wockhardt, recalled the repackaged product due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.

The affected lots include T-01082 (Exp 08/18), DR10445A (Exp 09/18), DR10443A (Exp 12/18), DR10445B (Exp 03/19), DR10725A (Exp 07/19), and DS10024A, DS10040A (Exp 10/19). The product is manufactured by Wockhardt Limited and distributed by Wockhardt USA LLC and Major Pharmaceuticals.

The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above and stop using the product if it matches the recall criteria.

The recalled product

Product
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…
Manufacturer
MAJOR PHARMACEUTICALS
Category
Drug — Prescription Medication
Hazard
Affected units
5,933

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Lot #: T-01082
  • Exp 08/18
  • DR10445A
  • Exp 09/18
  • DR10443A
  • Exp 12/18
  • DR10445B
  • Exp 03/19
  • DR10725A
  • Exp 07/19
  • DS10024A
  • DS10040A
  • Exp 10/19.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by MAJOR PHARMACEUTICALS under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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