The Recall Desk

FDA (Drugs) recall action 71684

Mutual Pharmaceutical Company, Inc. recalled 3 products on 2015-08-05

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2015-08-05
Critical
0
Units
20,892

Why these products were recalled

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Drugs)··2015-08-05

    Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2015-08-05

    Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2015-08-05

    Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    Mutual Pharmaceutical is recalling 20,892 bottles of Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
    Category
    Distribution
    0 states