PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures
PD-Rx Pharmaceuticals is recalling 3,440 bottles of Phentermine Hydrochloride capsules because stability tests showed out-of-specification unknown impurities.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which typically corresponds to a severity score of 1 or 2. A score of 2 is assigned as it involves a prescription drug with a quality specification failure (impurities) that is not likely to cause adverse health consequences but requires removal from the market.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling 3,440 bottles of Phentermine Hydrochloride Capsules, 15 mg. The affected products are available in 7-count, 14-count, 21-count, 30-count, and 60-count bottles. The recall is being conducted because out-of-specification results were found for individual unknown impurities during the 30th month Room Temperature Retained Sample stability test.
The recalled products were distributed nationwide. Specific lot numbers and expiration dates are listed in the official recall notice. The products were packaged by PD-Rx Pharmaceuticals, Incorporated, in Oklahoma City, OK, and manufactured by KVK-Tech, Inc. in Newtown, PA.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for guidance. 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.
The recalled product
- Product
- PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
- Brand
- PHENTERMINE HYDROCHLORIDE
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 3,440
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)
- Lots: a) H15E22
- Exp. 8/31/17
- J15E02
- Exp. 10/31/17. b) J15A53
- Exp. 10/31/17
- D16C78
- Exp.12/31/17
- c)J15D54
- d)H15B60
- e) J15A49
- C16A14
- Exp. 12/31/17.
UPCs (1)
- 0355289791607
Distribution
Distributed nationwide across the United States.
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