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
Reported: September 2, 2015 Initiated: July 14, 2015 #D-1371-2015
Product Description
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 for Recall
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Details
- Recalling Firm
- KVK-Tech, Inc.
- Units Affected
- 9,696 bottles (100-count), 972 bottles (1000-count)
- Distribution
- Nationwide
- Location
- Newtown, PA
Frequently Asked Questions
What product 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. Recalled by KVK-Tech, Inc.. Units affected: 9,696 bottles (100-count), 972 bottles (1000-count).
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2015. Severity: Low. Recall number: D-1371-2015.
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