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Recall Observatory FDA recall evidence

Drug product

CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

D-1224-2019

April 12, 2019

Class II

Product summary

Firm
CMC Enterprise Pharmacy
Event
Event 82620
Status
Terminated
Classification
Class II
Quantity
a) 150 bags; b)1369 syringes
Official record key
drug-enforcement:D-1224-2019

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: a) ED051904 Exp. 4/14/2019; ED081903 Exp. 4/17/2019; ED091903 Exp. 4/18/2019; ED111903 Exp. 4/20/2019; b) EB271904 Exp. 4/13/2019; EB281904 Exp. 4/14/2019; EC011903 Exp. 4/15/2019; EC051904 Exp. 4/19/2019; EC071904 Exp. 4/21/2019; EC081905 Exp. 4/22/2019; EC121905 Exp. 4/26/2019; EC131903 Exp. 4/27/2019; EC141903 Exp. 4/28/2019; EC151903 Exp. 4/29/2019; EC181904 Exp. 5/2/2019; EC191905 Exp. 5/3/2019; EC211904 Exp. 5/5/2019; EC221905 Exp. 5/6/2019; EC251904 Exp. 5/9/2019; EC271904 Exp. 5/11/2019; EC281904 Exp. 5/12/2019; ED011904 Exp. 5/16/2019; ED021906 Exp. 5/17/2019; ED031904 Exp. 5/18/2019; ED041903 Exp. 5/19/2019; ED051905 Exp. 5/20/2019; ED081904 Exp. 5/23/2019; ED091904 Exp. 5/24/2019; ED101904 Exp. 5/25/2019; ED111904 Exp. 5/26/2019

Distribution pattern: NC

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility