Class II · Moderate risk
neostigmine methylsulfate 5 mg/5 mL Injection
Lack of Assurance of Sterility
Neostigmine Methylsulfate Injection Solution 5 mg/5mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Affected NDC
42852-0829-67
Compare with the code on your package — it is the most precise check available.
Drug: Neostigmine
- Recalling firm
- Advanced Pharma Inc.
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1024-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Neostigmine recalls
See all
Class II · Moderate risk
neostigmine 5 mg/5mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Other recalls by Advanced Pharma Inc.
All 2019 recalls
Class II · Moderate risk
HYDROmorphone 20 mg/100 mL Injectable Solution
Sub-potency
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 30 mg/30 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
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