The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0797-2020·Announced 2020-01-29

Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

Preferred Pharmaceuticals is recalling Ranitidine Tablets, 300 mg, because the presence of the NDMA impurity was detected in the product.

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 agency classification is FDA Class II, and the presence of the NDMA impurity in a pharmaceutical product constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Ranitidine Tablets, 300 mg, Rx Only, in 14, 30, 90, and 100 count bottles. The recall involves 39,172 tablets across all lots within expiry.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The affected products were distributed to physicians in Alabama, Arizona, California, Florida, Georgia, Indiana, and South Carolina.

Patients who have been prescribed these specific NDCs (68788-6382-1, 68788-6382-3, 68788-6382-9, or 68788-6382-0) should contact their healthcare provider for further instructions or alternative treatment options.

The recalled product

Product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
Manufacturer
Preferred Pharmaceuticals, Inc
Category
Drug — Prescription Medication
Hazard
Affected units
39,172

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 (1)

  • Lot #: All lots within expiry

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 recalled by Preferred Pharmaceuticals, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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