Class II · Moderate risk Terminated
S-Amitriptyline 10mg/Ml Mdv Inj Soln
Reason Lack of Assurance of Sterility
Amitriptyline HCl USP for prescription compounding
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What was recalled
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8003-4
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0474-2018
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 Amitriptyline recalls
See all
Class III · Low risk Terminated
Amitriptyline HCl Tablets
Reason Cross Contamination With Other Product: Imipramine
Class II · Moderate risk Terminated
Amitriptyline HCL Tablets
Reason Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk Terminated
All ketamine and amitriptyline Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Amitriptyline HCl active pharmaceutical ingredient packaged in…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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