Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
Where it was sold
Product was distributed nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0010-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2017
- FDA report date
- Oct 25, 2017
- Quantity
- 96,876 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
Original FDA data
Every field from FDA enforcement report D-0010-2018, exactly as published.
Show all FDA fields
- City
- Hasbrouck Heights
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78218
- Address
- 777 Terrace Ave
- Address (line 2)
- Suite 102
- Code information
- Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
- Postal code
- 07604-3102
- Report date
- Oct 25, 2017
- Product type
- Drugs
- Recall number
- D-0010-2018
- Classification
- Class II
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
- Product quantity
- 96,876 bottles
- Termination date
- Sep 13, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Product was distributed nationwide
- Recall initiation date
- Oct 2, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 18, 2017