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Recall Observatory FDA recall evidence

Drug product

Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

D-1219-2019

April 12, 2019

Class II

Product summary

Firm
CMC Enterprise Pharmacy
Event
Event 82620
Status
Terminated
Classification
Class II
Quantity
3690 bags
Official record key
drug-enforcement:D-1219-2019

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: EA241909 Exp. 4/24/2019; EA281909 Exp. 4/28/2019; EA301910 Exp. 4/30/2019; EB111909 Exp. 5/12/2019; EB141909 Exp. 5/15/2019; EB221908 Exp. 5/23/2019; EC061908 Exp. 6/4/2019; EC131909 Exp. 6/11/2019; EC261910 Exp. 6/24/2019

Distribution pattern: NC

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility

Field note

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