Class II · Moderate risk Terminated
S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
Reason Lack of Assurance of Sterility
Is Amitriptyline recalled?
6 FDA recalls mention Amitriptyline. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amitriptyline.
Class II · Moderate risk Terminated
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class III · Low risk Terminated
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC…
Reason Cross Contamination With Other Product: Imipramine
Class II · Moderate risk Terminated
Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL…
Reason Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk Terminated
All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Amitriptyline HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
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…
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