Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

FDA recall notice · announced January 4, 2017 · Sandoz

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

Reason for recall

Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

Notes

Distribution: MS and OH.
Lot/code information: Lot GG1539
Quantity: 96 bottles
Status: Terminated
Products in this recall event:
- Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10 (D-0236-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.