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Recall Observatory FDA recall evidence

Drug product

Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059

D-0918-2018

June 29, 2018

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 80425
Status
Terminated
Classification
Class II
Quantity
3984 syringes
Official record key
drug-enforcement:D-0918-2018

Official wording

Reason: Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.

Code information: Lot #: 20180507@21, Exp 7/1/2018; 20180511@9, 20180511@24, Exp 7/5/2018; 20180518@24, 20180518@31, 20180518@32, Exp 7/12/2018; 20180531@21, Exp 7/25/2018; 20180601@11, Exp 7/26/2018

Distribution pattern: United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent