Reported Aug 5, 2015 · Terminated
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC…
Mutual Pharmaceutical Company, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mutual Pharmaceutical Company, Inc. · 1100 Orthodox St · Philadelphia, PA · 19124-3168
Is this the product you have?
- 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
- Lot codes and dates
Lot #: a) 6624001 exp 2/166630501 exp 3/166669001 exp 12/166676201 exp 1/176680701 exp 2/17b) 66240026624201 exp 2/166630601 exp 3/166668901 exp 12/1666760016676101 exp 1/1766794016679501exp 2/17
- Amount recalled
- a) 96,640 bottles; b) 17,808 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
This product could cause temporary or reversible health problems — stop using it.
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