Tacrolimus Compounded Suspension Recalled Due to Subpotency
Valor Compounding Pharmacy recalls compounded Tacrolimus 0.5 mg/mL suspension due to subpotency. The medication, distributed in California, may not provide adequate therapeutic levels for immunosuppression in transplant patients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is an FDA Class I recall. Per the severity rubric, FDA Class I classification mandates a minimum score of 4. Although no illnesses or injuries are reported in the source, the subpotency of an immunosuppressant carries serious risk of treatment failure in transplant patients.
Plain-English summary
Valor Compounding Pharmacy is recalling compounded Tacrolimus 0.5 mg/mL suspension. The affected lot is 03312022@29 with a Beyond Use Date of June 10, 2022, supplied in multiple bottle sizes (12 oz, 2 oz, 16 oz, and 6 oz). The product was distributed in California.
The recall was issued due to subpotency: the medication contains less active ingredient than specified. Tacrolimus is an immunosuppressant used to prevent organ rejection in transplant patients. Subpotent medication may fail to provide adequate therapeutic levels, creating a serious risk of transplant rejection.
Patients who received this medication should contact their healthcare provider and Valor Compounding Pharmacy immediately, providing the lot number and Beyond Use Date. The recall was initiated voluntarily on April 15, 2022, and terminated on November 7, 2022.
The recalled product
- Product
- Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704,
- Category
- Drug — Immunosuppressant
- 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 #: 03312022@29
- BUD: 6/10/2022
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy 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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