Recalls / Class II
Class IID-0236-2017
Product
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
- Affected lot / code info
- Lot GG1539
Why it was recalled
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 96 bottles
- Distribution pattern
- MS and OH.
Timeline
- Recall initiated
- 2016-12-22
- FDA classified
- 2016-12-27
- Posted by FDA
- 2017-01-04
- Terminated
- 2017-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0236-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.