FDA Recalls Injectable Ascorbic Acid Vials Due to Sterility Concerns
Oregon Compounding Centers is recalling injectable ascorbic acid vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.
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 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 from infection.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vials. The recall involves 7,900 mL of product distributed in Oregon and Washington.
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 all lots of sterile products compounded by the pharmacy that are not expired. The agency has classified this recall as Class II.
Consumers and healthcare providers should check their inventory for the following lot numbers and discard dates: Lot # 20140827@34 (discard date 10/26/2014), Lot # 20140909@22 (discard date 11/8/2014), and Lot # 20140912@2 (discard date 11/11/2014). If you have these products, do not use them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
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 (6)
- Lot #: 20140827@34
- discard date: 10/26/2014
- Lot #: 20140909@22
- discard dae: 11/8/2014
- Lot #: 20140912@2
- discard date: 11/11/2014.
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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