Bi-Mix Injection Recalled Due to Lack of Assurance of Sterility
Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product was distributed nationwide.
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 FDA classified this recall as Class II. A lack of assurance of sterility in an injectable drug presents a significant risk of serious health consequences, such as infection, which aligns with the 'Severe' severity criteria.
Plain-English summary
Pharm D Solutions, LLC is recalling Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL), NDC 69699-1317-03. The recall is being conducted because of a lack of assurance of sterility. The affected product quantity is 115 milliliters.
The recall covers lots 04112018:50 (Discard by: 10/7/2018) and 08082018:53 (Discard by: 2/4/2019). The product was distributed nationwide. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund.
The recalled product
- Product
- Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 115
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: 04112018:50 Discard by: 10/7/2018
- 08082018:53 Discard by: 2/4/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 79 recalled by Pharm D Solutions, LLC 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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