Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
Aidarex Pharmaceuticals is recalling 25 bottles of Enalapril Maleate 5mg due to out-of-specification degradation results during stability testing.
What this means for you
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
Aidarex Pharmaceuticals LLC is recalling 25 bottles of Enalapril Maleate, USP 5mg, 30-count bottles. The product is prescription-only and was distributed nationwide in the USA. The recall involves specific lots with expiration dates ranging from January 2018 to May 2018.
The recall was initiated because of out-of-specification results for the Enalapril Diketopiperazine degradation product detected during commercial stability testing. This indicates that the chemical composition of the drug did not meet the required standards for stability over time.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (9)
- Lots: 51904-2
- EXP: 01/31/2018
- 51904-3
- EXP: 02/28/2018
- 51904-5
- EXP: 03/31/2018
- 52885-2
- 53840-1
- EXP: 5/28/2018.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Aidarex Pharmaceuticals LLC 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 3 products in this recall →Related recalls
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