Why it was recalled
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Product description
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
Lot numbers, UPCs & expiration codes
Lot: 757739, EXP 9/2020
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-0128-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 22, 2018
- FDA report date
- Nov 7, 2018
- Quantity
- 1,380 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0128-2019, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 81340
- Address
- 900 Ridgebury Rd
- Code information
- Lot: 757739, EXP 9/2020
- Postal code
- 06877-1058
- Report date
- Nov 7, 2018
- Product type
- Drugs
- Recall number
- D-0128-2019
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 1,380 100-count bottles
- Termination date
- Apr 3, 2023
- Reason for recall
- Failed Dissolution Specifications: OOS resultsduring routine stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
- Distribution pattern
- Distributed nationwide in the USA and Puerto Rico
- Recall initiation date
- Oct 22, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2018