FDA-Drug2014-02-05Class II
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Wockhardt Usa Inc.
Hazard
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Sold states
Nationwide including Puerto Rico
Affected count
1129 bottles
Manufactured in
20 Waterview Blvd., Suite 3, Parsippany, NJ, United States
Products
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1042-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief