Chlorothiazide Syringes Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 60 syringes of Chlorothiazide 100 mg 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. Lack of sterility assurance in injectable drugs poses a significant risk of infection.
Plain-English summary
CMC Enterprise Pharmacy is recalling 60 syringes of Chlorothiazide 100 mg, 3.57 mL, due to a lack of sterility assurance. The affected product was manufactured by Enterprise Pharmacy in Charlotte, North Carolina.
The recall involves specific lots with expiration dates in April 2019: ED041908 (Exp. 4/18/2019), ED051909 (Exp. 4/19/2019), and ED081908 (Exp. 4/22/2019). The product was distributed in North Carolina.
Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 60
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 (3)
- Lots: ED041908 Exp. 4/18/2019
- ED051909 Exp. 4/19/2019
- ED081908 Exp. 4/22/2019
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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