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.
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 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.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — Antibiotic
- Hazard
- 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.
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