Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
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.
Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
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).
Failed Content Uniformity Specifications
Subpotent Drug
Subpotent Drug
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.