CLASS II Drug recall · Reported 2 May 2018 · FDA Enforcement Report
NEOstigmine Methylsulfate (1 mg/mL) 3mg per Single Dose Syringe recalled
Premier Pharmacy Labs is recalling NEOstigmine Methylsulfate (1 mg/mL) 3mg per Single Dose Syringe, distributed nationwide in the US. The recall was initiated on 11 Apr 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0702-2018
- FDA event ID
- 79803
- Recalling firm
- Premier Pharmacy Labs, Weeki Wachee, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2018
- FDA classified
- 26 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 11 Apr 2018 | Recall initiated by company | |
| 26 Apr 2018 | Classified by FDA | +15 days |
| 2 May 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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.
Which lots are affected?
Lot: NEO022218SVDS BUD: 8/21/2018
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 79803| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Morphine Sulfate 2 mg/mL PF Injection recalled by Premier Pharmacy Labs | Premier Pharmacy Labs | Sterility | Nationwide | |
| CLASS II | Morphine Sulfate 4 mg/mL PF Injection recalled by Premier Pharmacy Labs | Premier Pharmacy Labs | Sterility | Nationwide | |
| CLASS II | Hydromorphone HCl 1 mg/mL PF INJ recalled by Premier Pharmacy Labs | Premier Pharmacy Labs | Sterility | Nationwide |
More recalls from Premier Pharmacy Labs
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naloxone HCL Preserved INJ, 500mg/ (10mg/mL) Sterile MDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate Sterile Injectable Solution *Contains recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Preservative Free Irrigation, 40mg/ (4mg/mL) SDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg recalled | Premier Pharmacy Labs | Sterility | Nationwide |
Other Neostigmine Methylsulfate recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | neostigmine methylsulfate 5 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 3 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 5 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 4 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 5 mg/ (1 mg/mL) recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |