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.

FDA recall notice · announced May 2, 2018 · Premier Pharmacy Labs

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: NEO022218SVDS BUD: 8/21/2018
Quantity: 600 syringes
Status: Terminated
Products in this recall event:
- Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10 (D-0699-2018)
- Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10 (D-0700-2018)
- Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10 (D-0701-2018)
- 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. (D-0702-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.