The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0796-2020·Announced 2020-01-29

Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

Preferred Pharmaceuticals is recalling 150 mg Ranitidine tablets because of detected NDMA impurity. The affected products were distributed to physicians in seven states.

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. According to the rubric, FDA Class II recalls involving significant health risks like NDMA impurities are categorized as Severe (Score 4), particularly when hospitalization reports or significant injury risks are associated with the hazard class, though the source text does not explicitly report hospitalizations, the Class II designation for a drug impurity aligns with the Severe criteria for significant risk.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling 150 mg Ranitidine tablets due to the presence of the NDMA impurity. The recall includes 30, 60, 90, and 100-count bottles with specific NDC codes. The total quantity involved is 221,710 tablets.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The source text does not specify which lots are affected other than stating 'All lots within expiry.'

The affected products were distributed to physicians in Alabama, Arizona, California, Florida, Georgia, Indiana, and South Carolina. Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or physician for guidance on alternatives.

The recalled product

Product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
Manufacturer
Preferred Pharmaceuticals, Inc
Category
Drug — Prescription Medication
Hazard
Affected units
221,710

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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