Ganciclovir Syringes Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Ganciclovir syringes due to quality control issues affecting sterility assurance identified 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 recall is classified as FDA Class II and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling Ganciclovir, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringes. The recall involves 20 syringes from Lot # 20140911@9 with a discard date of 10/26/2014. The product was distributed in Oregon and Washington.
The recall was initiated due to a lack of sterility assurance. This was identified during a recent FDA inspection, which observed quality control procedures that present a potential risk to sterility assurance for all lots of sterile products compounded by the pharmacy that are not expired.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Injectable
- Hazard
- Affected units
- 20
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 #: 20140911@9
- discard date: 10/26/2014
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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