Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Reported: January 29, 2020 Initiated: December 11, 2019 #D-0798-2020
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.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 4,486 tablets
- Distribution
- Product was distributed to two facilities in CA and NY.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00. Recalled by RemedyRepack Inc.. Units affected: 4,486 tablets.
Why was this product recalled? ▼
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 29, 2020. Severity: Moderate. Recall number: D-0798-2020.
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