Dexmedetomidine Bag (CMC Enterprise) – Sterility Risk (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Brand
CMC Enterprise Pharmacy
Lot Codes / Batch Numbers
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
Products Sold
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
CMC Enterprise Pharmacy is recalling Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. due to Lack of sterility assurance.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of sterility assurance.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC
Page updated: Jan 21, 2026