The Recall Desk
SevereFDA (Drugs)·D-1227-2019·Announced 2019-05-01

CMC Enterprise Pharmacy Recalls CefTRIAXone Syringes Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 15 syringes of CefTRIAXone 1 GM 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 and involves a lack of sterility assurance in an injectable medication, which poses a risk of serious injury or death if administered.

Plain-English summary

CMC Enterprise Pharmacy is recalling 15 syringes of CefTRIAXone 1 GM, 100 mg/mL, 10 mL. The recall is being conducted because of a lack of sterility assurance in the product. The medication was manufactured by Enterprise Pharmacy in Charlotte, North Carolina.

The affected lots are EB271907 (expiration date 4/13/2019) and ED041907 (expiration date 5/19/2019). The recall is classified as Class II by the FDA. The product was distributed in North Carolina.

Consumers and healthcare providers should stop using the affected syringes and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Affected units
15

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 (2)

  • Lots: EB271907 Exp. 4/13/2019
  • ED041907 Exp. 5/19/2019

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 →