The Recall Desk
ModerateFDA (Drugs)·D-1282-2015·Announced 2015-08-05

Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

Mutual Pharmaceutical is recalling 20,892 bottles of Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

What this means for you

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, but the source text does not report any illnesses or injuries, and the hazard is a cGMP deviation (dispensing in unauthorized rooms) rather than a confirmed high-risk pathogen or structural defect. This aligns with the 'Moderate' criteria for voluntary precautionary recalls or low-risk contamination where no harm is reported.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling 20,892 bottles of Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles. The affected product is identified by NDC 53489-217-01 and includes Lot # 6676701 and 6676801, with an expiration date of 1/17. The product was distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the Clonidine hydrochloride drug substance used in the manufacturing of this product was dispensed in unauthorized rooms by the drug substance manufacturer. This deviation raises concerns about the quality and safety of the medication.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
20,892

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 #: 6676701 and 6676801
  • exp 1/17

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Mutual Pharmaceutical Company, 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 3 products in this recall →

Related recalls

Same manufacturer · Mutual Pharmaceutical Company, Inc.

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Same hazard · cGMP deviation

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