Recalls / Class II
Class IID-1280-2015
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
- Affected lot / code info
- 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
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
Recalling firm
- Firm
- Mutual Pharmaceutical Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1100 Orthodox St, N/A, Philadelphia, Pennsylvania 19124-3168
Distribution
- Quantity
- a) 96,640 bottles; b) 17,808 bottles
- Distribution pattern
- Nartionwide
Timeline
- Recall initiated
- 2015-07-09
- FDA classified
- 2015-07-30
- Posted by FDA
- 2015-08-05
- Terminated
- 2016-10-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1280-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.