The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1209-2019·Announced 2019-05-01

Dexmedetomidine Bags Recalled for Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 5,678 bags of Dexmedetomidine 400 mcg in NS 100 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury reports are Severe. While the source does not explicitly state hospitalizations, the lack of sterility assurance in an IV medication is a significant hazard that aligns with the Severe criteria for Class II recalls involving potential serious harm.

Plain-English summary

CMC Enterprise Pharmacy is recalling 5,678 bags of Dexmedetomidine 400 mcg in NS 100 mL. The recall was initiated because the product lacks sterility assurance. The affected lots include EA141908, EA171909, EA211906, EA251908, EB041905, EB071907, EB151909, EC041906, EC111907, EC181908, and EC201907, with expiration dates ranging from April 14, 2019, to June 18, 2019.

The recall is classified as FDA Class II. The affected products were distributed in North Carolina. The source text does not specify the number of patients affected or report any illnesses or injuries.

Healthcare providers and consumers should stop using the affected lots and contact CMC Enterprise Pharmacy for further instructions or a refund.

The recalled product

Product
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — IV Medication
Hazard
Affected units
5,678

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 32 recalled by CMC Enterprise Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

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