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Recall Observatory FDA recall evidence

Drug product

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.

D-0333-2019

December 05, 2018

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 81730
Status
Terminated
Classification
Class II
Quantity
295 50 ml in 60 ml syringes
Official record key
drug-enforcement:D-0333-2019

Official wording

Reason: Sub-potent

Code information: Lot: 183220013C Exp. 12/19/2018

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sub-potent