Apotex Recalls Cyclosporine Capsules Due to Impurity Failures
Apotex Inc. is recalling 19,584 bottles of Cyclosporine Capsules, USP, 100 mg, because the product failed impurity specifications.
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 source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant quality failures like out-of-specification impurities.
Plain-English summary
Apotex Inc. is voluntarily recalling 19,584 bottles of Cyclosporine Capsules, USP, 100 mg, 30 count bottles. The product is identified by Lot MJ9837, with an expiration date of 07/2017, NDC 60505-0134-0, and UPC 360505013401. The capsules were manufactured by Apotex, Inc. in Toronto, Ontario, Canada, for Apotex Corp. in Weston, FL.
The recall was initiated because the product failed impurities and degradations specifications. Specifically, the product yielded out-of-specification results for Maximum Unknown Impurities and Total Impurities. The affected product was distributed nationwide.
Consumers who have this specific lot of Cyclosporine Capsules should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CYCLOSPORINE (CYCLOSPORINE)
- Brand
- CYCLOSPORINE
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 19,584
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 (3)
- Lot MJ9837
- Exp 07/2017. NDC 60505-0134-0
- UPC 360505013401
UPCs (1)
- 360505013401
Distribution
Distributed nationwide across the United States.
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