Recalls / Class II
Class IID-0798-2020
Product
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
- Affected 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
Why it was recalled
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 4,486 tablets
- Distribution pattern
- Product was distributed to two facilities in CA and NY.
Timeline
- Recall initiated
- 2019-12-11
- FDA classified
- 2020-01-20
- Posted by FDA
- 2020-01-29
- Terminated
- 2020-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0798-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.