Alara Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Issues
Alara Pharmaceutical is recalling 7,432 bottles of Levothyroxine Sodium Tablets because the product is subpotent and has stability issues.
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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no specific injuries are reported, the subpotent nature of a thyroid medication poses a significant health risk, aligning with the Severe criteria for Class II drug recalls.
Plain-English summary
Alara Pharmaceutical Co is recalling 7,432 bottles of Levothyroxine Sodium Tablets, USP, 175 mcg. The product was manufactured by Patheon Puerto Rico Inc. for Alara Pharmaceutical Corp in San Juan, PR. The recall is due to the product being subpotent and having 15-month stability issues.
The affected product is distributed nationwide. The specific lot code is 11T7011A with an expiration date of 12/2012.
Consumers should check their medication for this specific lot code and expiration date. If they have the affected product, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
- Manufacturer
- Alara Pharmaceutical Co
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,432
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)
- 11T7011A
- Exp. Date: 12/2012
Distribution
Distributed nationwide across the United States.
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