Alteplase Syringes Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 97 syringes of Alteplase 1 mg/mL 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. According to the rubric, FDA Class II recalls with potential for serious injury (such as lack of sterility assurance in injectable drugs) are classified as Severe.
Plain-English summary
CMC Enterprise Pharmacy is recalling 97 syringes of Alteplase 1 mg/mL 1 mL in 10 mL syringe. The recall was initiated because of a lack of sterility assurance in the product. The affected lots are ED021901 (expiration date 5/17/2019) and ED031921 (expiration date 5/18/2019).
The product was manufactured by Enterprise Pharmacy, located at 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. The recall is limited to distribution in North Carolina.
Consumers and healthcare providers should stop using the affected syringes and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Alteplase 1 mg/mL 1 mL in 10 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
- 97
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: ED021901 Exp. 5/17/2019
- ED031921 Exp. 5/18/2019
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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