Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
Compare with the code on your package — it is the most precise check available.
Drug: Hyoscyamine
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.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
cGMP deviations
cGMP deviations
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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