Physicians Total Care Recalls Subpotent Levothyroxine Tablets
Physicians Total Care is recalling Levothyroxine Tablets, USP, 0.175 mg, due to subpotency and stability issues. The recall affects specific lots distributed in Ohio 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 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 source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is a Class II recall involving a subpotent drug (which implies a risk of therapeutic failure), it falls into the Severe category (Score 4) as it is not a Class I recall but involves a significant quality defect in a prescription medication.
Plain-English summary
Physicians Total Care, Inc. is recalling Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles. The recall is due to the product being subpotent and having a 15-month stability issue as noted by the manufacturer.
The affected product is identified by NDC 54868-4507-00, lot code 6WX2, and expiration date 12/31/2012. The recall covers 90 pills per bottle. Distribution was limited to Ohio and Georgia.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 90
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)
- 6WX2 exp 12/31/2012
Distribution
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