Sentara Recalls Meropenem Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling Meropenem in NS Homepumps because product sterility cannot be guaranteed. The recall affects 192 bags distributed in Virginia and 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 the hazard involves a lack of assurance of sterility for an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Sentara Enterprises is recalling specific lots of MEROPENEM in NS, packaged as 1000MG in 250ML Homepumps and 2GM in 100ML Homepumps. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed. The affected products are prescription-only and were compounded between September 11, 2015, and September 17, 2015.
The recall includes 159 bags of the 1000MG in 250ML formulation and 33 bags of the 2GM in 100ML formulation. These products were distributed in the United States, specifically in Virginia and North Carolina. The expiration dates for the affected lots range from September 16, 2015, to September 24, 2015.
Consumers and healthcare providers should stop using the affected products and contact Sentara Home Health Sentara RX at 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176, for further instructions or a replacement.
The recalled product
- Product
- MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
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 (7)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 18-Sep-15
- 20-Sep-15
- 21-Sep-15
- 22-Sep-15
- 23-Sep-15
- 24-Sep-15 b) 16-Sep-15
- 19-Sep-15
Distribution
Part of a larger recall action
This product is one of 34 recalled by Sentara Enterprises 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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