FDAFDA · Food and drugs·Recall number D-0010-2018
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.
Published October 25, 2017 · Recall initiated: October 2, 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
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BISOPROLOL FUMARATE
- Manufacturer
- Unichem Pharmaceuticals Usa Inc
- Distributor
- Product was distributed nationwide
- UPC
- 0329300126136
- Lot
- Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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