FDA Recalls Compounded Tacrolimus Suspension Due to Subpotency
Valor Compounding Pharmacy issued a Class I recall for compounded Tacrolimus suspension (Lot 04272022@35) distributed in California due to subpotency.
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: FDA Class I classification requires minimum Severe (4) rating per agency standards. Although no illnesses or injuries were reported in the source, subpotency of an immunosuppressant medication poses serious risk to transplant patients.
Plain-English summary
Valor Compounding Pharmacy in Berkeley, California has recalled compounded Tacrolimus 0.5 mg/mL suspension. The affected lot is 04272022@35 (beyond-use date 7/7/2022), with a total of 950 mL distributed in California in 1x8 oz and 2x16 oz bottles.
The FDA classified this as a Class I recall on June 27, 2022, due to the medication being subpotent. Subpotency indicates the drug was below the specified strength.
The pharmacy voluntarily initiated this recall on April 15, 2022. The recall was terminated on November 7, 2022.
Patients taking this medication should contact their healthcare provider to discuss the recall and confirm the strength of their medication supply.
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 — Compounded Medication
- 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 #: 04272022@35
- BUD: 7/7/2022.
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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