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Recall Observatory FDA recall evidence

Drug product

Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

D-1216-2019

April 12, 2019

Class II

Product summary

Firm
CMC Enterprise Pharmacy
Event
Event 82620
Status
Terminated
Classification
Class II
Quantity
196 bags
Official record key
drug-enforcement:D-1216-2019

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: EA111909 Exp. 7/10/2019; EB061910 Exp. 8/5/2019; EB131909 Exp. 8/12/2019

Distribution pattern: NC

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility