FDA Recalls Lidoaine HCL Solution Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Lidoaine HCL solution for irrigation due to quality control issues affecting 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 a sterile product, which poses a significant risk of infection or serious injury.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Lidoaine HCL (REPKG-STERILE), 4%, solution for irrigation. The affected products are packaged in 5 mL, 6 mL, and 7 mL plastic dropper bottles and are prescription (RX) items. The recall includes 49 5 mL bottles, 40 6 mL bottles, and 30 7 mL bottles from Lot # 20140815@12, which has a discard date of 2/16/2015.
The recall is being conducted 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 agency has classified this recall as Class II.
The affected products were distributed in Oregon and Washington. Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, 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 (2)
- Lot #: 20140815@12
- discard date: 2/16/2015
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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