Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations
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.
VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.
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: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP deviations
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