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Recall Observatory FDA recall evidence

Drug product

atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.

D-0026-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
5568 syringes
Official record key
drug-enforcement:D-0026-2017

Official wording

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Code information: Lot Numbers: 15146082M, 15147001M, 15147099M, 15149110M, 15150028M, 15152055M, 151730002M, 151730129M, 151880317M, 151880330M, 151890300M, 151930022M, 151940213M, 151940288M, Exp between 07/15/15-10/12/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    loss of potency