Reported Oct 25, 2017 · Terminated
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind.…
Unichem Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Unichem Pharmaceuticals Usa Inc · 777 Terrace Ave · Hasbrouck Heights, NJ · 07604-3102
Is this the product you have?
- Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only
- Manufactured byUNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India
- Marketed byUNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13
- Lot codes and dates
Lot #: GBOL16001GBOL16002Exp 12/31/2017GBOL16015Exp 03/31/2018
- Amount recalled
- 96,876 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
This product could cause temporary or reversible health problems — stop using it.
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