Vancomycin Injectable Syringes Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Vancomycin injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.
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 source text identifies a 'lack of sterility assurance' for an injectable drug, which presents a significant risk of serious injury or infection. Per the rubric, significant injury reports or structural defects in high-risk products align with a Severe (4) rating.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling 12 syringes of VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe. The product is a prescription medication manufactured in Wilsonville, Oregon, and distributed in Oregon and Washington.
The recall was initiated due to a lack of sterility assurance. This issue stems from quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection. The specific lot number is 20140905@32, with a discard date of 10/20/2014.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Injectable
- Affected units
- 12
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 #: 20140905@32
- discard date: 10/20/2014
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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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