Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Phentermine HCL Blue Speckled tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
Affected NDC
10702-0025-10
Compare with the code on your package — it is the most precise check available.
Drug: Phentermine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Phentermine Hydrochloride NDC 10702-0025 |
37.5 mg/1 | Tablet Oral |
KVK-TECH, Inc. | Rx · CIV |
- Recalling firm
- Calvin Scott & Company, Inc.
- NDC code
- 10702-0025-10
- Origin
- NM, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1532-2020 · FDA notice
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.
Other Phentermine recalls
See all
Class II · Moderate risk
Phentermine HCL 37.5mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Phentermine HCL 30mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Phentermine
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Phentermine HCL White/Blue Speckled tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Other recalls by Calvin Scott & Company, Inc.
All 2020 recalls
Class I · High risk
Benzonatate 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.
Class III · Low risk
Benzphetamine tablets
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.
Class II · Moderate risk
Phentermine
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
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