Sodium Bicarbonate IV Bags Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 100 bags of Sodium Bicarbonate 150 mEq in D5W 1000 mL due to lack of sterility assurance.
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 intravenous product, which poses a significant risk of serious injury or death if administered.
Plain-English summary
CMC Enterprise Pharmacy is recalling 100 bags of Sodium Bicarbonate 150 mEq in D5W 1000 mL. The recall was initiated due to a lack of sterility assurance for the product.
The affected product was manufactured by Enterprise Pharmacy, located at 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. The recall covers specific lots with expiration dates ranging from April 13, 2019, to April 20, 2019. The product was distributed in North Carolina.
Healthcare providers and patients should stop using the recalled product and contact their pharmacy or healthcare provider for further instructions.
The recalled product
- Product
- Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 100
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 (8)
- Lots: ED041913 Exp. 4/13/2019
- ED051913 Exp. 4/14/2019
- ED081913 Exp. 4/17/2019
- ED091913
- ED091912 Exp. 4/18/2019
- ED101914
- ED101913 Exp. 4/19/2019
- ED111911 Exp. 4/20/2019
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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