D-0798-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2020
- Initiation Date
- December 11, 2019
- Termination Date
- July 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,486 tablets
Product Description
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Reason for Recall
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Distribution Pattern
Product was distributed to two facilities in CA and NY.
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