Agency classClass IIOur severity:Severe FDA (Drugs)·D-0617-2020·Announced 2019-12-18

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Drug — Prescription/OTC Medication
Hazard: ndma-impurity
cgmp-deviation
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

Distributed in 2 states:

Same manufacturer · Preferred Pharmaceuticals, Inc

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Same hazard · ndma impurity