Sentara Recalls Clindamycin Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling 6 bags of Clindamycin 120mg in NS Homepumps because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable medications.
Plain-English summary
Sentara Enterprises is recalling 6 bags of CLINDAMYCIN 120MG in NS, packaged in 20ML Homepumps, which are prescription-only. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected lots were compounded between September 11, 2015, and September 17, 2015, and have an expiration date of September 29, 2015. These products were distributed in the United States, specifically in Virginia and North Carolina.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or Sentara Home Health Sentara Rx for further instructions.
The recalled product
- Product
- CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Injectable
- Hazard
- Affected units
- 6
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 (1)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-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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