Why it was recalled
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Product description
Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).
Lot numbers, UPCs & expiration codes
lot #14071112AA; Exp. 03/14. lot #14071112AB; Exp. 03/14. lot # 14071012BA; Exp. 03/14. lot #14071012BB; Exp 03/14.
Where it was sold
Nationwide
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-1074-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 18, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 1,249,700 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1074-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67141
- Address
- 425 Privet Rd
- Code information
- lot #14071112AA; Exp. 03/14. lot #14071112AB; Exp. 03/14. lot # 14071012BA; Exp. 03/14. lot #14071012BB; Exp 03/14.
- Postal code
- 19044-1220
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1074-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 1,249,700 tablets
- Termination date
- Oct 22, 2014
- Reason for recall
- Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2014