Class I · High risk
Prograf (tacrolimus)
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
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
Drug: Tacrolimus
- Recalling firm
- Synergy Rx
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0526-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Synergy Rx
All 2017 recalls
Class II · Moderate risk
Kojic Acid 8%/Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Intimate Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Gentle Supreme Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Custom Lightening/Brightening Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
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