PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures
PD-Rx Pharmaceuticals is recalling 1,685 bottles of Phentermine Hydrochloride capsules because stability tests showed impurities exceeded specifications.
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 indicates the product is unlikely to cause adverse health consequences. The issue is a failure in impurity specifications during stability testing, with no reported injuries or illnesses.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling 1,685 bottles of Phentermine Hydrochloride Capsules, USP, 15 mg. The product is available in 7-count, 14-count, 28-count, 30-count, and 60-count bottles. The recall was initiated because the product failed impurities and degradation specifications, specifically showing out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station.
The affected product was distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation, including lots H14C80, I14G36, H14A86, H14C83, K14A21, H14F25, and L14C42. The capsules were manufactured by KVK-TECH, INC and packaged by PD-RX Pharmaceuticals, INC.
Consumers should check their medication for the specific NDC codes and lot numbers listed in the official recall notice. If the product matches the recalled items, patients should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
- Brand
- PHENTERMINE HYDROCHLORIDE
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 1,685
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 (12)
- Lot #: a) H14C80
- Exp 08/16
- I14G36
- Exp 09/16
- b) H14A86
- Exp 07/16
- c) H14C83
- K14A21
- Exp 11/16
- d) H14F25
- e) L14C42
- Exp 12/16.
UPCs (1)
- 0355289791607
Distribution
Distributed nationwide across the United States.
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