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Recall Observatory FDA recall evidence

Drug product

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-947-50

D-1248-2022

June 30, 2022

Class II

Product summary

Firm
Nephron Sterile Compounding Center LLC
Event
Event 90512
Status
Terminated
Classification
Class II
Quantity
1380 syringes
Official record key
drug-enforcement:D-1248-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: BL2007A, Exp. 7/3/2022

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility