Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
Reported: March 18, 2020 Initiated: November 20, 2019 #D-1003-2020
Product Description
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
Reason for Recall
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 53,619 cartons
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11. Recalled by American Health Packaging. Units affected: 53,619 cartons.
Why was this product recalled? ▼
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 18, 2020. Severity: Moderate. Recall number: D-1003-2020.
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