Phentermine Hydrochloride Capsules
cGMP deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
Compare with the code on your package — it is the most precise check available.
Drug: Phentermine
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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
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