Why it was recalled
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Product description
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.
Lot numbers, UPCs & expiration codes
Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0502-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 5, 2017
- FDA report date
- Mar 8, 2017
- Quantity
- 22,915 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0502-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76543
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
- Postal code
- 08512-3605
- Report date
- Mar 8, 2017
- Product type
- Drugs
- Recall number
- D-0502-2017
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 22,915 bottles
- Termination date
- Jun 29, 2018
- Reason for recall
- Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Jan 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2017