Phentermine Hydrochloride Capsules recall: Impurity Out of Spec
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
Why was Phentermine Hydrochloride Capsules recalled?
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
- 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
- Recalling firm
- KVK-Tech, Inc.
- Quantity
- 9,696 bottles (100-count), 972 bottles (1000-count)
- Distribution
- Nationwide
- Recall date
- September 2, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)