Why it was recalled
An extraneous peak was observed for dissolution testing.
Product description
Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
Lot numbers, UPCs & expiration codes
Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022
Where it was sold
Distributed Nationwide in the USA and Puerto Rico
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-0051-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 5, 2020
- FDA report date
- Nov 4, 2020
- Quantity
- 13,270 bottles/100 tablets each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0051-2021, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 86527
- Address
- 900 Ridgebury Rd
- Code information
- Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022
- Postal code
- 06877-1058
- Report date
- Nov 4, 2020
- Product type
- Drugs
- Recall number
- D-0051-2021
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 13,270 bottles/100 tablets each
- Termination date
- Sep 29, 2021
- Reason for recall
- An extraneous peak was observed for dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico
- Recall initiation date
- Oct 5, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2020