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
Reported: August 5, 2015 Initiated: July 9, 2015 #D-1280-2015
Product Description
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
Reason for Recall
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Details
- Recalling Firm
- Mutual Pharmaceutical Company, Inc.
- Units Affected
- a) 96,640 bottles; b) 17,808 bottles
- Distribution
- Nartionwide
- Location
- Philadelphia, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mutual Pharmaceutical Company, Inc.. Units affected: a) 96,640 bottles; b) 17,808 bottles.
Why was this product recalled? ▼
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 5, 2015. Severity: Moderate. Recall number: D-1280-2015.
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