The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1218-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls Norepinephrine Bags Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 2,567 bags of Norepinephrine 16 mg in NS 250 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 involves a lack of sterility assurance in an injectable medication, which poses a significant risk of infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

CMC Enterprise Pharmacy is recalling 2,567 bags of Norepinephrine 16 mg in NS 250 mL. The recall was initiated because of a lack of sterility assurance in the manufacturing process. The affected products were manufactured by Enterprise Pharmacy in Charlotte, North Carolina.

The recall covers nine specific lots with expiration dates ranging from April 15, 2019, to June 11, 2019. The distribution of these products was limited to North Carolina. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should check their inventory and medication records for the specific lot numbers listed in the recall notice. If you have been administered these specific bags, you should contact your healthcare provider for guidance. Do not use the recalled products.

The recalled product

Product
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — Injectable Medication
Hazard
Affected units
2,567

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 (9)

  • Lots: EA151909 Exp. 4/15/2019
  • EA251907 Exp. 4/25/2019
  • EA301909 Exp. 4/30/2019
  • EA311911 Exp. 5/1/2019
  • EB131910 Exp. 5/14/2019
  • EB201910 Exp. 5/21/2019
  • EB271909 Exp. 5/28/2019
  • EC081910 Exp. 6/6/2019
  • EC131908 Exp. 6/11/2019

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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