Reported Aug 23, 2017 · Terminated
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles…
KVK-Tech, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KVK-Tech, Inc. · 110 Terry Dr · Newtown, PA · 18940-3427
Is this the product you have?
- Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd
- byKVK-TECH, INC. NEWTOWN, PA 18940
- Lot codes and dates
- Lot #
- a)
12322A12323B12324AExp. Sep 201712455AExp. Dec 2017b) 12323AExp. Sep 201712456AExp. Dec 2017
- Amount recalled
- 35,267 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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