Clonidine Hydrochloride Tablets recall: CGMP Deviations
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
Why was Clonidine Hydrochloride Tablets recalled?
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 6676701 and 6676801, exp 1/17
- Product
- Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- Quantity
- 20,892 bottles
- Distribution
- Nartionwide
- Recall date
- August 5, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)