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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.

D-0087-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
2985 syringes
Official record key
drug-enforcement:D-0087-2017

Official wording

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

Code information: Lot Numbers: 15112107M, 15112110M, 15112113M, 15113025, 15113077M, 15113092M, 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