Why it was recalled
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Product description
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Lot numbers, UPCs & expiration codes
Lot # 34033752A, EXP 1/2020
Where it was sold
Product was distributed throughout the United States to various distributors who may have further distributed the product.
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-0082-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 20, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 1,373 60-count cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0082-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81069
- Address
- 1090 Horsham Rd
- Code information
- Lot # 34033752A, EXP 1/2020
- Postal code
- 19454-1505
- Report date
- Oct 24, 2018
- Product type
- Drugs
- Recall number
- D-0082-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 1,373 60-count cartons
- Termination date
- Nov 7, 2019
- Reason for recall
- Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
- Distribution pattern
- Product was distributed throughout the United States to various distributors who may have further distributed the product.
- Recall initiation date
- Sep 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 18, 2018