Phentermine Hydrochloride Capsules
cGMP deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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.
Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70
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.
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
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.
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.