Tobramycin Solution Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Tobramycin solution for irrigation due to quality control issues affecting sterility assurance.
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 the hazard involves a lack of sterility assurance in a sterile product, which poses a significant risk of serious injury or infection.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Tobramycin, 480mg/1000 mL, solution for irrigation. The product is packaged in 500 mL plastic bottles and is a prescription medication.
The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection of the pharmacy. The agency classification for this recall is Class II.
The affected product was distributed in Oregon and Washington. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Antibiotic Solution
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 #: 20140912@16
- discard date: 10/17/2014
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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