The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1219-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls Oxytocin Bags Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 3,690 bags of Oxytocin 30 units in NS 500 mL due to a lack of sterility assurance. The product was 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the classification and the nature of the defect (sterility) align with the Severe criteria for drug recalls.

Plain-English summary

CMC Enterprise Pharmacy is recalling 3,690 bags of Oxytocin 30 units in NS 500 mL. The recall was initiated because of a lack of sterility assurance in the product. The affected bags were manufactured by Enterprise Pharmacy in Charlotte, North Carolina, and distributed within North Carolina.

The recall covers specific lots with expiration dates ranging from April 24, 2019, to June 24, 2019. The FDA 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 stop using the affected Oxytocin bags and contact CMC Enterprise Pharmacy for further instructions or a replacement. Consumers should not use the product if they have received it.

The recalled product

Product
Oxytocin 30 units in NS 500 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
3,690

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: EA241909 Exp. 4/24/2019
  • EA281909 Exp. 4/28/2019
  • EA301910 Exp. 4/30/2019
  • EB111909 Exp. 5/12/2019
  • EB141909 Exp. 5/15/2019
  • EB221908 Exp. 5/23/2019
  • EC061908 Exp. 6/4/2019
  • EC131909 Exp. 6/11/2019
  • EC261910 Exp. 6/24/2019

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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