Teva Recalls Moexipril Hydrochloride Tablets Due to Impurity Test Failure
Teva Pharmaceuticals is recalling specific bottles of Moexipril Hydrochloride and Hydrochlorothiazide tablets because routine stability testing found high levels of a degradation impurity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when associated with significant quality failures like impurity specification breaches.
Plain-English summary
Teva Pharmaceuticals USA is recalling 4,969 bottles of Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count. The affected product is identified by Lot # 30229439A and has an expiration date of 12/17. The recall was initiated after routine stability testing revealed a high out-of-specification test result for the Moexipril Diketopiperazine impurity.
The recalled medication was distributed nationwide in the USA. This is a prescription-only medication. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on alternative treatment options. The product should be returned to the pharmacy or destroyed according to local regulations.
The recalled product
- Product
- Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,969
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 (2)
- Lot # 30229439A
- Exp 12/17
Distribution
Distributed nationwide across the United States.
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