Bisoprolol Fumarate tablets recall: Impurity Out of Spec
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa…
Why was Bisoprolol Fumarate tablets recalled?
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
- Product
- Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa…
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
- Quantity
- 96,876 bottles
- Distribution
- Product was distributed nationwide
- Recall date
- October 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)