The Recall Desk
ModerateFDA (Drugs)·D-1280-2015·Announced 2015-08-05

Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

Mutual Pharmaceutical is recalling 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, which typically involves a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The source text describes a cGMP deviation regarding the dispensing location of the drug substance but does not report any specific illnesses, injuries, or deaths, nor does it identify a specific high-risk pathogen or allergen mislabeling. Therefore, it fits the 'Moderate' criteria for a voluntary precautionary recall or minor labeling/quality error without reported harm.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling Clonidine Hydrochloride Tablets, USP, 0.1 mg, in 100-count and 1,000-count HDPE bottles. The recall involves specific lot numbers and expiration dates ranging from February 2016 to February 2017. The affected products were 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 finished drug product.

Patients and healthcare providers should discontinue use of the affected lots and contact their healthcare provider for alternative treatment options. The recalling firm is responsible for managing the recall and ensuring the removal of affected products from the market.

The recalled product

Product
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard

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 (14)

  • Lot #: a) 6624001 exp 2/16
  • 6630501 exp 3/16
  • 6669001 exp 12/16
  • 6676201 exp 1/17
  • 6680701 exp 2/17
  • b) 6624002
  • 6624201 exp 2/16
  • 6630601 exp 3/16
  • 6668901 exp 12/16
  • 6676001
  • 6676101 exp 1/17
  • 6679401
  • 6679501
  • exp 2/17

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.

See all →

Same hazard · cGMP deviation

See all →