Mylan Recalls Tacrolimus Capsules Due to Potential Foreign Capsule Presence
Mylan Pharmaceuticals is recalling specific lots of 5mg Tacrolimus capsules because 1mg capsules may be present in the bottles.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 FDA classified this as a Class III recall, which indicates a low probability of adverse health consequences. The hazard involves a potential dosage error due to a foreign capsule, which is a significant quality issue but does not meet the criteria for higher severity scores without reported injuries.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 3,816 bottles of Tacrolimus Capsules, USP 5mg, 100-count. The recall involves Lot # 3105410 and 3106268, with an expiration date of 9/2020. The product is distributed nationwide in the U.S.A.
The recall was initiated due to the potential presence of a foreign tablet or capsule. Specifically, there is a risk that one 1 mg Tacrolimus capsule may be commingled in the 5 mg bottles. This discrepancy could result in patients receiving an incorrect dosage of the medication.
Consumers who have these specific lot numbers should stop using the product and contact their healthcare provider or pharmacist for guidance. The affected product is a prescription-only oral medication manufactured by Mylan Pharmaceuticals Inc. in Morgantown, WV.
The recalled product
- Product
- TACROLIMUS (TACROLIMUS)
- Brand
- TACROLIMUS
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 3,816
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 (3)
- Lot # 3105410
- 3106268
- Exp 9/2020
UPCs (3)
- 0303782046014
- 0303782045017
- 0303782047011
Distribution
Distributed nationwide across the United States.
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