PANTOPRAZOLE SODIUM Recall D-0852-2022
Description: 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.
PANTOPRAZOLE SODIUM Recall D-0852-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0852-2022 |
| Event ID | 89992 |
| Brand | PANTOPRAZOLE SODIUM |
| Generic Name | PANTOPRAZOLE SODIUM |
| Manufacturer | PANTOPRAZOLE SODIUM |
| Original Package? | 1 |
| Active Substance | PANTOPRAZOLE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S.A |
| Quantity | 24,888 bottles |
| Recall Reason | CGMP deviations: tablets cracking |
| Drug Classification | Class II |
| Drug Code Info | 20220511 |
| Product NDC | 13668-096 13668-429 |
| Drug UPC | 0313668429305 0313668096309 |
| Recall Initiation Date | 20220411 |
| Report Date | 20220511 |
| Classification Date | 20220505 |
| Address | 2091 Hartel Ave Levittown, PA 19057-4506 United States |
| Recalling Firm | Torrent Pharma Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6871619Q5X |
| Drug Application Number | ANDA090074 |
| Structured Product Labeling (SPL ID) | c2dde4e5-88b0-436e-a89c-c8854ae0b686 |
| Structured Product Labeling (SPL Set ID) | 9c983da1-a8e0-479e-8816-5d5668ea242e |
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