Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
National Drug Code
Is NDC 49035-0404-13 recalled?
Ranitidine Tablets
Yes — this exact package was recalled
1 FDA recall names the code 49035-0404-13 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Class II · Moderate risk
Ranitidine Hydrochloride Tablets
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 49035-0882 See recall 3
- 49035-0125 See recall 2
- 49035-0229 Acne Treatment 2
- 49035-0273 See recall 2
- 49035-0313 Equate Childrens Pain and Fever 2
- 49035-0592 See recall 2
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