FDA Recalls Ganciclovir Syringes Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling 40 syringes of Ganciclovir due to quality control issues affecting sterility assurance found during an FDA inspection.
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 agency classification is FDA Class II. The hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection, fitting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Ganciclovir -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringes manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The recall involves 40 syringes from Lot # 20140916@16, which had a discard date of 10/31/2014.
The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility assurance of sterile products compounded by the pharmacy. The source text indicates that all lots of sterile products compounded by the pharmacy that are not expired are subject to this concern.
The affected products were distributed in Oregon and Washington. Consumers and healthcare providers should stop using the recalled syringes and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Injectable
- Affected units
- 40
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 #: 20140916@16
- discard date: 10/31/2014
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.
See all 56 products in this recall →Related recalls
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