Clonidine Hydrochloride Tablets recalled over manufacturing violations
- Recall date
- July 9, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mutual Pharmaceutical Company, Inc. recalls Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-…
- Recall number
- D-1280-2015
- FDA classification
- Class II
- Brand / firm
- Mutual Pharmaceutical Company, Inc.
- Sold / distributed
- Nartionwide
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
Get recall alerts
Free email alert whenever Mutual Pharmaceutical Company, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Mutual Pharmaceutical Company, Inc.