FDA Drug recall D-1371-2015
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01
- FDA Drug
- Class III
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class III recall of Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01 by Kvk Tech, citing failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1371-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-14 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Kvk Tech |
| Distribution | US |
Product
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
Reason
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Identifiers
| upc | 310702026018 |
|---|---|
| upc | 310702026010 |
| code_info | Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-05-28 · Kvk Tech - Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd
FDA Drug · Class II · 2025-05-28 · Kvk Tech - Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01
FDA Drug · Class I · 2023-10-25 · Kvk Tech - Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd
FDA Drug · Class I · 2021-09-01 · Kvk Tech - Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1371-2015%22
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