Why it was recalled
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Product description
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
Lot numbers, UPCs & expiration codes
Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016
Where it was sold
Nationwide
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-924-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 6, 2013
- FDA report date
- Sep 4, 2013
- Quantity
- 9003 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-924-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 65912
- Address
- 650 Cathill Rd
- Code information
- Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016
- Postal code
- 18960-1512
- Report date
- Sep 4, 2013
- Product type
- Drugs
- Recall number
- D-924-2013
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 9003 Bottles
- Termination date
- Aug 27, 2014
- Reason for recall
- Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2013