Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity
Preferred Pharmaceuticals is recalling specific lots of Ranitidine Tablets 150 mg because the FDA detected the presence of the NDMA impurity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant health risks or potential for serious injury, even without reported fatalities.
Plain-English summary
Preferred Pharmaceuticals, Inc. is voluntarily recalling 316 bottles of Ranitidine Tablets, USP 150 mg, OTC. The affected products are available in 30-count and 60-count bottles manufactured by Amneal Pharmaceuticals. The recall involves specific lots with expiration dates of 12/20, distributed in California and Florida.
The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. NDMA is a chemical that can form in certain medications and is considered a potential carcinogen.
Consumers who have purchased these specific bottles should stop using the product and contact their healthcare provider or the recalling firm for instructions on how to return the medication or obtain a replacement.
The recalled product
- Product
- Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Affected units
- 316
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: I2519H
- Exp. 12/20
- I2719O
- J1419O
- J2819L
Distribution
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