Class II
Terminated
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
- Company
- Remedyrepack Inc.
- Recall Initiated
- December 11, 2019
- Posted
- January 29, 2020
- Recall Number
- D-0798-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,486 tablets
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Distribution
Product was distributed to two facilities in CA and NY.
Lot / Code Info
Lot #: J0376034-052319, exp. date 05/2020 Lot #: J0406133-093019, exp. date 10/2020 Lot #: J038005-082719, exp. date 08/2020 Lot #: J0390280-072519, exp. date 07/2020 Lot #: J0390277-072519, exp. date 07/2020 Lot #: J0349352-012519, exp. date 01/2020
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