Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations
Preferred Pharmaceuticals is recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.
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 2/5 (Moderate).
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 II due to CGMP deviations, which fits the rubric for moderate severity involving voluntary precautionary recalls or minor quality issues without reported serious harm.
Plain-English summary
Preferred Pharmaceuticals, Inc. is voluntarily recalling Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. tablets. The recall involves 90-count bottles of repackaged tablets manufactured by RLC Labs in Cave Creek, Arizona, and distributed by Preferred Pharmaceuticals. The specific lot number is B2618E, with an expiration date of 2/28/2021.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians located in California and Georgia. The recall was initiated on September 2, 2020, and the FDA classified it as Class II.
Patients who have been prescribed this specific lot of Nature-Throid should contact their healthcare provider for guidance on alternative treatment options. The recall status is currently terminated.
The recalled product
- Product
- Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Thyroid Medication
- Hazard
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 (2)
- Lot #: B2618E
- Exp. Date: 2/28/2021
Distribution
Part of a larger recall action
This product is one of 4 recalled by Preferred Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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