Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 30229439A, Exp 12/17
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0208-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 14, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 4,969 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0208-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 78753
- Address
- 1090 Horsham Rd
- Code information
- Lot # 30229439A, Exp 12/17
- Postal code
- 19454-1505
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0208-2018
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 4,969 bottles
- Termination date
- Oct 1, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2018