KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures
KVK-Tech, Inc. is recalling specific lots of Phentermine Hydrochloride capsules because they failed impurity specifications during stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
KVK-Tech, Inc. is recalling 35,267 bottles of Phentermine Hydrochloride Capsules, USP 15 mg. The affected products are packaged in 100-count and 1,000-count bottles and were distributed nationwide in the United States.
The recall was initiated because the product failed impurity and degradation specifications. Out-of-specification results were obtained for individual unknown impurities found during a 30-month room temperature retained sample stability test. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
- Brand
- PHENTERMINE HYDROCHLORIDE
- Manufacturer
- KVK-Tech, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 35,267
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot # a):12322A
- 12323B
- 12324A
- Exp. Sep 2017
- 12455A
- Exp. Dec 2017
- b) 12323A
- 12456A
UPCs (3)
- 0310702027107
- 0310702028104
- 0310702026100
Distribution
Distributed nationwide across the United States.
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