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 is remote or theoretical risk of temporary or medically reversible adverse health consequences. The hazard is a cGMP deviation (unauthorized dispensing room) without reported illnesses or injuries, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate score.
Plain-English summary
Mutual Pharmaceutical Company, Inc. is recalling Clonidine Hydrochloride Tablets, USP, 0.2 mg, in 100-count and 1,000-count HDPE bottles. The recall involves specific lot numbers with expiration dates in 2016 and 2017. The product is distributed nationwide and is available by prescription only.
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 process deviation raises concerns about the quality and safety of the finished drug product.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for alternative treatment options. The recalling firm, Mutual Pharmaceutical Company, Inc., is responsible for managing the recall and providing further information to affected parties.
The recalled product
- Product
- Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
- Manufacturer
- Mutual Pharmaceutical Company, Inc.
- Category
- Drug — Prescription Medication
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 (6)
- Lot #: a) 6643901
- exp 5/16
- 6677201
- exp 1/17
- b) 6677101
- 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.
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