Tacrolimus Capsules Recalled for Wrong-Strength Tablets Co-Mingled in Bottles
Dr. Reddy's Laboratories is recalling Tacrolimus 0.5 mg capsules due to the presence of one 1 mg capsule co-mingled in affected bottles. The mismatched capsule could lead to incorrect dosing in immunosuppressed patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a medication dosage mix-up. Although no illnesses have been reported, the incorrect dose of this immunosuppressant could cause serious adverse effects. The hazard represents risk-of-harm products where injury has not yet been reported.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Tacrolimus Capsules, USP, 0.5 mg, 100-count bottles (Lot # C2106445, expiration 03/2024) distributed nationwide in the United States. The recall was initiated because one Tacrolimus 1 mg capsule was found co-mingled in bottles labeled as containing 0.5 mg capsules.
Tacrolimus is an immunosuppressant medication used to prevent organ rejection after transplantation and to treat certain autoimmune conditions. The presence of a higher-strength capsule in a bottle labeled with a lower strength creates a risk that a patient could unknowingly take an incorrect dose, potentially resulting in serious adverse effects.
Patients who are currently taking Tacrolimus from the affected lot should contact their healthcare provider or pharmacist to verify whether their bottle may be affected. Patients should not discard their medication without consulting a healthcare professional first, as Tacrolimus typically requires careful management and supervised dosing changes.
The recalled product
- Product
- TACROLIMUS (TACROLIMUS)
- Brand
- TACROLIMUS
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- medication-error
- wrong-strength
- co-mingling
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 # C2106445
- Exp. 03/2024
UPCs (3)
- 0355111527015
- 0355111525011
- 0355111526018
Distribution
Distributed nationwide across the United States.
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