Reported May 1, 2019 · Terminated
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India;…
Zydus Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only
- Manufactured byCadila Healthcare Ltd., India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
- Lot codes and dates
Lot #: Z803518Exp 08/2020
- Amount recalled
- 7668 bottles
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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