Why it was recalled
Failed Dissolution Test Requirements
Product description
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
Lot numbers, UPCs & expiration codes
Lot #308198, Expiration Date is 03/2014
Where it was sold
FL, NJ.
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-160-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 20, 2012
- FDA report date
- Feb 20, 2013
- Quantity
- 60 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Upsher Smith Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-160-2013, exactly as published.
Show all FDA fields
- City
- Maple Grove
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 63908
- Address
- 6701 Evenstad Drive
- Code information
- Lot #308198, Expiration Date is 03/2014
- Postal code
- 55369
- Report date
- Feb 20, 2013
- Product type
- Drugs
- Recall number
- D-160-2013
- Classification
- Class II
- Recalling firm
- Upsher Smith Laboratories, Inc.
- Product quantity
- 60 bottles
- Termination date
- Jul 12, 2013
- Reason for recall
- Failed Dissolution Test Requirements
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
- Distribution pattern
- FL, NJ.
- Recall initiation date
- Nov 20, 2012
- Initial firm notification
- Telephone
- Center classification date
- Feb 8, 2013