Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Subpotent Drug
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.
Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
Drug: Buprenorphine
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.
Labeling: Label Mix-up
Crystallization; identified as Buprenorphine free base
Crystallization; identified as Buprenorphine free base
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
CGMP Deviations
Subpotent Drug
Subpotent Drug
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