Home / Recalls / CMC Enterprise Pharmacy / D-1209-2019

D-1209-2019 Class II Terminated

Recalled by CMC Enterprise Pharmacy — Charlotte, NC

Recall Details

Product Type
Drugs
Report Date
May 1, 2019
Initiation Date
April 12, 2019
Termination Date
October 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5678 bags

Product Description

Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

NC

Code Information

Lots: EA141908 Exp. 4/14/2019; EA171909 Exp. 4/17/2019; EA211906 Exp. 4/21/2019; EA251908 Exp. 4/25/2019; EB041905 Exp. 5/6/2019; EB071907 Exp. 5/8/2019; EB151909 Exp. 5/16/2019; EC041906 Exp. 6/2/2019; EC111907 Exp. 6/9/2019; EC181908 Exp. 6/16/2019; EC201907 Exp. 6/18/2019

Other recalls by CMC Enterprise Pharmacy

  • D-1219-2019 Class II — Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acre (April 12, 2019)
  • D-1225-2019 Class II — CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enter (April 12, 2019)
  • D-1235-2019 Class II — Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acr (April 12, 2019)
  • D-1211-2019 Class II — Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres (April 12, 2019)
  • D-1233-2019 Class II — Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 44 (April 12, 2019)
  • D-1215-2019 Class II — Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf (April 12, 2019)
  • D-1212-2019 Class II — Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 (April 12, 2019)
  • D-1213-2019 Class II — Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf (April 12, 2019)
  • D-1238-2019 Class II — Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharm (April 12, 2019)
  • D-1227-2019 Class II — CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 G (April 12, 2019)