Drug product
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
D-0798-2020
Product summary
- Event
- Event 84696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,486 tablets
- Official record key
drug-enforcement:D-0798-2020
Official wording
Reason: CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Code information: 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
Distribution pattern: Product was distributed to two facilities in CA and NY.
Derived failure modes
-
Manufacturing or process control
CGMP Deviation