Baxter Recalls Dopamine Hydrochloride Bags Due to Sterility Concerns
Baxter Healthcare is recalling 11,808 bags of Dopamine Hydrochloride and Dextrose due to a potential manufacturing defect that may compromise sterility.
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 involves a lack of assurance of sterility in an intravenous drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Baxter Healthcare Corp. is recalling 11,808 bags of Dopamine Hydrochloride and 5% Dextrose Injection, USP (NDC 0338-1005-02). The affected product is identified by Lot # P303172 and has an expiration date of 12/14. The product was distributed nationwide and in Canada.
The recall was initiated due to a lack of assurance of sterility. A small cut in the solution bag may have been introduced during the manufacturing process, which resulted in a leak of the bag into the overpouch. This defect raises concerns about the sterility of the intravenous solution.
Healthcare providers and patients should discontinue use of the affected product. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- DOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE)
- Brand
- DOPAMINE HYDROCHLORIDE AND DEXTROSE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 11,808
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)
- Lot# P303172
- Exp. 12/14
Distribution
Distributed nationwide across the United States.
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