Why it was recalled
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Product description
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, 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# 29300-137-01
Lot numbers, UPCs & expiration codes
Lot # GCLH22005, exp. date 02/29/2024
Where it was sold
Distributed Nationwide in the USA
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-1541-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 19, 2022
- FDA report date
- Sep 28, 2022
- Quantity
- 18,960 bottles of 100
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC
Original FDA data
Every field from FDA enforcement report D-1541-2022, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90709
- Address
- 1 Tower Center Blvd Ste 2200
- Code information
- Lot # GCLH22005, exp. date 02/29/2024
- Postal code
- 08816-1145
- Report date
- Sep 28, 2022
- Product type
- Drugs
- Recall number
- D-1541-2022
- Classification
- Class III
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC
- Product quantity
- 18,960 bottles of 100
- Termination date
- Mar 2, 2023
- Reason for recall
- Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, 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# 29300-137-01
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Sep 19, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2022