FDA-Drug2022-05-11Class II

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

Torrent Pharma Inc
Hazard

CGMP deviations: tablets cracking

Sold states
Nationwide in the U.S.A
Affected count
24,888 bottles
Manufactured in
2091 Hartel Ave, N/A, Levittown, PA, United States
Products
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0852-2022

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