PD-Rx Pharmaceuticals Recalls Famotidine 20 mg Tablets for Weight Issues
PD-Rx Pharmaceuticals is recalling 100 bottles of Famotidine USP 20 mg tablets because they failed to meet tablet weight specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a failure to meet tablet weight specifications, which is a quality control issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling 100 bottles of Famotidine USP 20 mg tablets. The product is identified by NDC 55289-765-30, Lot A17F55, and an expiration date of 06/30/2018. The recall was initiated because the tablets failed to meet the required specification for tablet weight.
The affected product was distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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: A17F55 Exp. 06/30/2018
Distribution
Distributed nationwide across the United States.
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