Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Phentermine Hydrochloride Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
Affected NDCs
10702-0026-01
10702-0026-10
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 10702-0026 |
15 mg/1 | Capsule Oral |
KVK-Tech, Inc. | Rx · CIV |
- Recalling firm
- KVK-Tech, Inc.
- NDC code
- 10702-0026-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1371-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 Blue Speckled tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Other recalls by KVK-Tech, Inc.
All 2015 recalls
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
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