Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Clonidine Hydrochloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
Affected NDCs
53489-0216-01
53489-0216-10
Compare with the code on your package — it is the most precise check available.
Drug: Clonidine
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- NDC code
- 53489-216-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1281-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clonidine recalls
See all
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class III · Low risk
Clonidine Hydrochloride Tablets
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Other recalls by Mutual Pharmaceutical Company, Inc.
All 2015 recalls
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
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