Class II · Moderate risk
neostigmine methylsulfate 5 mg/5 mL Injection
Lack of Assurance of Sterility
NEOstigmine Methylsulfate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
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 (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.
Affected NDC
69623-0234-14
Compare with the code on your package — it is the most precise check available.
Drug: Neostigmine
- Recalling firm
- Premier Pharmacy Labs Inc
- NDC code
- 69623-234-14
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0702-2018 · 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 Premier Pharmacy Labs Inc
All 2018 recalls
Class II · Moderate risk
SUCCINYLcholine Chloride
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
SUCCINYLcholine Chloride
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Sodium Bicarbonate INJ 8.4%
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Riboflavin 5-Phosphate Sodium Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
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