FDAFDA · Food and drugs·Recall number D-0502-2017
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.
Published March 8, 2017 · Recall initiated: January 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ALFUZOSIN HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico.
- UPC
- 0347335956818
- Lot
- Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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