PD-Rx Recalls Nature-Throid Tablets Due to CGMP Deviations and Sub-Potency Risk
PD-Rx Pharmaceuticals is recalling 20 bottles of Nature-Throid 1 GR tablets due to CGMP deviations and potential sub-potency. The product was distributed in Arizona and Oklahoma.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sub-potent medication, which poses a significant risk of therapeutic failure and potential harm to patients relying on thyroid hormone replacement.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling 20 bottles of Nature-Throid 1 GR (65 mg) tablets. The specific lot number is J18C68, with an expiration date of 10/31/20. The product is a prescription medication containing Thyroid USP, Liothyronine (T3), and Levothyroxine (T4).
The recall was initiated because the repackaged product was manufactured under the same conditions as other products found to be sub-potent. Additionally, Current Good Manufacturing Practice (CGMP) deviations were identified. The FDA has classified this recall as Class II.
The affected product was distributed in Arizona and Oklahoma. Consumers who possess this specific lot of Nature-Throid should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Category
- Drug — Thyroid Hormone
- Hazard
- Affected units
- 20
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 (1)
- Lot #: J18C68 Exp. 10/31/20
Distribution
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