CMC Enterprise Pharmacy Recalls Heparin Pork Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 87 bags of Heparin Pork 30,000 Units in NS 1000 mL due to a lack of sterility assurance. The product was 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance in a parenteral drug is a significant hazard that aligns with the Severe classification for Class II recalls.
Plain-English summary
CMC Enterprise Pharmacy is recalling 87 bags of Heparin Pork 30,000 Units in NS 1000 mL. The recall was initiated because of a lack of sterility assurance for the product.
The affected lots are ED091908 (expiration date 4/18/2019) and ED101908 (expiration date 4/19/2019). The product was manufactured by Enterprise Pharmacy in Charlotte, North Carolina, and distributed within North Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 87
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: ED091908 Exp. 4/18/2019
- ED101908 Exp. 4/19/2019
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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