27 FDA recalls mention Tacrolimus. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tacrolimus.
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Reason Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg 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…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Defective Container: Tube split from side seam
Reason Subpotent drug
Reason Subpotent drug
Reason Failed Moisture Limits
Reason Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Processing Controls
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Reason Labeling: Label Mixup; TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125 mcg, NDC 00074706890…
Reason Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5…
Reason Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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