The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1004-2020·Announced 2020-03-18

Precision Dose Recalls Ranitidine Oral Solution Due to NDMA Impurity

Precision Dose Inc. is recalling Ranitidine Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

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 with significant injury reports or structural defects are Severe; while no specific injuries are listed, the presence of NDMA, a known carcinogen, in a Class II drug recall aligns with the Severe tier for significant potential harm.

Plain-English summary

Precision Dose Inc. is recalling Ranitidine Oral Solution, USP, 150 mg/10 mL, in unit dose cups. The recall involves 224,940 unit dose cups distributed nationwide in the United States. The specific NDCs affected are 68094-204-61, 68094-204-62, and 68094-204-59.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the impurity N-nitrosodimethylamine (NDMA) was found in the active pharmaceutical ingredient (API). The affected lots include 501290, 501326, 501501, 1592, and 501679, with expiration dates ranging from November 30, 2019, to April 30, 2020.

This is a prescription-only medication. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments or replacements. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Manufacturer
Precision Dose Inc.
Category
Drug — Oral Solution
Hazard
Affected units
224,940

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 (10)

  • Lot number: 501290
  • Expiry: 11/30/19
  • NDC: 68094-204-61
  • Lot number: 501326
  • NDC: 68094-204-62
  • Lot number: 501501
  • Lot number: 1592
  • Expiry: 4/30/20
  • Lot number: 501679
  • 68094-204-62

Distribution

Distributed nationwide across the United States.

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