Fagron Sterile Services Recalls Two Lots of Neostigmine Methylsulfate 1 mg/mL – APhA submits compounding comments to FDA. – (866) 348-2889.
Fagron Sterile Services is recalling two lots of neostigmine methylsulfate 5 mL syringes to the user, hospital, and/or clinic level because of a confirmed customer complaint. As stated in the recall announcement, the complaint indicates that some syringe units containing neostigmine methylsulfate 1 mg/mL, 5 mg per 5 mL are incorrectly labelled as neostigmine methylsulfate 1 mg/mL, 3 mg per 3 mL. Secondary packages are properly labelled as neostigmine methylsulfate 1 mg/mL, 5 mg per 5mL.
Neostigmine methylsulfate injection, USP, is supplied by Fagron Sterile Services in a single-use syringe and is produced by the company into 5 mL or 3 mL fill presentation of 1 mg/mL of neostigmine methylsulfate. The affected lots – C274-000004690 and C274-000004678 – were distributed nationwide directly to hospitals and surgical clinics. The product descriptions are as follows: