Why it was recalled
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Product description
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Lot numbers, UPCs & expiration codes
Lot GG1539
Where it was sold
MS and OH.
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-0236-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2016
- FDA report date
- Jan 4, 2017
- Quantity
- 96 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-0236-2017, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 76077
- Address
- 2555 W Midway Blvd
- Code information
- Lot GG1539
- Postal code
- 80020-1632
- Report date
- Jan 4, 2017
- Product type
- Drugs
- Recall number
- D-0236-2017
- Classification
- Class II
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 96 bottles
- Termination date
- Sep 18, 2017
- Reason for recall
- Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
- Distribution pattern
- MS and OH.
- Recall initiation date
- Dec 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 27, 2016