Class I · High risk Ongoing
Prograf
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: There are also CGMP Deviations.
What was recalled
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676
- Recalling firm
- Synergy Rx
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0526-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tacrolimus recalls
See all
Class I · High risk Ongoing
Astagraf XL
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk Terminated
Tacrolimus Capsules
Reason Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II · Moderate risk Ongoing
Tacrolimus Capsules
Reason 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 Terminated
Tacrolimus 0.03% Oph Solution Tacrolimus 0.1%
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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