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.
Reported: March 8, 2017 Initiated: January 5, 2017 #D-0502-2017
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.
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.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 22,915 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 22,915 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2017. Severity: Moderate. Recall number: D-0502-2017.
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