The Recall Desk
SevereFDA (Drugs)·D-1234-2019·Announced 2019-05-01

Sodium Citrate Syringes Recalled for Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 40 syringes of Sodium Citrate 4% due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

What this means for you

Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While the source does not explicitly state reported injuries, the lack of sterility assurance in a medical product is a significant hazard that aligns with the Severe classification for Class II recalls.

Plain-English summary

CMC Enterprise Pharmacy is recalling 40 syringes of Sodium Citrate 4%, 40 mg/mL, 3 mL Flush Syringes. The recall is being conducted because the product lacks sterility assurance. The specific lots affected are ED031915, ED041919, ED091914, and ED111912, with expiration dates ranging from April 17, 2019, to April 25, 2019.

The affected products were distributed in North Carolina. The source text does not specify the number of units distributed or the specific facilities where the product was sold.

Consumers and healthcare providers should stop using the affected syringes and contact CMC Enterprise Pharmacy for further instructions or a refund.

The recalled product

Product
Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — Pharmaceutical
Hazard
Affected units
40

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 (4)

  • Lots: ED031915 Exp. 4/17/2019
  • ED041919 Exp. 4/18/2019
  • ED091914 Exp. 4/23/2019
  • ED111912 Exp. 4/25/2019

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 →

Related recalls

Same manufacturer · CMC Enterprise Pharmacy

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Same hazard · lack of sterility

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