Why it was recalled
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Product description
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
Lot numbers, UPCs & expiration codes
Lot #: F47008, Exp. 7/2015
Where it was sold
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
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-1430-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 29, 2014
- FDA report date
- Jul 16, 2014
- Quantity
- 8,472 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1430-2014, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68441
- Address
- 1090 Horsham Rd
- Code information
- Lot #: F47008, Exp. 7/2015
- Postal code
- 19454-1505
- Report date
- Jul 16, 2014
- Product type
- Drugs
- Recall number
- D-1430-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 8,472 Bottles
- Termination date
- Mar 9, 2015
- Reason for recall
- Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
- Distribution pattern
- Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
- Recall initiation date
- May 29, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 10, 2014