Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Tacrolimus
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Subpotent drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704,
Drug: Tacrolimus
- Recalling firm
- Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1167-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tacrolimus recalls
See all
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk
Tacrolimus 0.03% Oph Solution Tacrolimus 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
All 2022 recalls
Class I · High risk
Nifedipine WSP 0.2% Ointment
Subpotent and Superpotent Drug
Class I · High risk
Tacrolimus
Subpotent drug
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