FDAFDA · Food and drugs·Recall number D-1280-2015
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
Published August 5, 2015 · Recall initiated: July 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mutual Pharmaceutical Company, Inc.
- Distributor
- Nartionwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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