The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0559-2016·Announced 2016-01-06

PD-Rx Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

PD-Rx Pharmaceuticals is recalling 9 bottles of Clonidine Hydrochloride Tablets, 0.1 mg, distributed in Alabama due to cGMP deviations.

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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses or injuries, and the hazard is related to manufacturing deviations rather than a specific high-risk pathogen or structural defect.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is voluntarily recalling 9 bottles of Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles. The product is prescription-only and was packaged by PD-Rx Pharmaceuticals, Inc. in Oklahoma City, OK, and manufactured by Mutual Pharm. Co. Inc. in Philadelphia, PA. The specific lot number is B14D26 with an expiration date of 02/16.

The recall was initiated because of Current Good Manufacturing Practice (cGMP) deviations. The affected product was distributed in Alabama. The recall was initiated on July 10, 2015, and was classified as Class II by the FDA.

Consumers who have this specific lot of Clonidine Hydrochloride Tablets should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall was terminated on March 8, 2017.

The recalled product

Product
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
9

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 (2)

  • Lot# B14D26
  • Exp 02/16

Distribution

Distributed in 1 state:

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