Class II · Moderate risk Ongoing
Lysine for Injection
Reason Lack of Assurance of Sterility
Lysine HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Recalling firm
- Promise Pharmacy, LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0477-2019
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 Lysine recalls
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Class II · Moderate risk Completed
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Reason Super Potent and Failed Reconstitution Time
Class II · Moderate risk Ongoing
Goal
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Goal-Glutamine 75mg/Ornithine 75mg/Arginine 150mg/Lysine…
Reason Lack of assurance of sterility
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