Class II · Moderate risk Ongoing
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by…
Reason CGMP Deviations: use of an unapproved raw material
Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Temperature abuse
What was recalled
Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- NDC code
- 61314-665-05
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1026-2022
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 Clonidine recalls
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Class II · Moderate risk Ongoing
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by…
Reason CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk Ongoing
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by…
Reason CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk Ongoing
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50…
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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