Why it was recalled
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Product description
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01
Lot numbers, UPCs & expiration codes
Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
Where it was sold
Nationwide within the United States
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-1291-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 26, 2020
- FDA report date
- Jun 17, 2020
- Quantity
- 190,992 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC
Original FDA data
Every field from FDA enforcement report D-1291-2020, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85764
- Address
- 1 Tower Center Blvd Ste 2200
- Code information
- Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
- Postal code
- 08816-1145
- Report date
- Jun 17, 2020
- Product type
- Drugs
- Recall number
- D-1291-2020
- Classification
- Class III
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC
- Product quantity
- 190,992 bottles
- Termination date
- Jan 8, 2021
- Reason for recall
- Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 26, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2020