Fresenius Kabi Recalls Rifampin Injection Due to Impurity Failures
Fresenius Kabi is recalling 7,593 vials of Rifampin for Injection because the product failed impurity and degradation 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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage (implied by impurity failures in an IV drug) are rated as Severe (4).
Plain-English summary
Fresenius Kabi USA, LLC is recalling 7,593 vials of Rifampin for Injection, USP 600mg/vial in a 20mL vial. The affected product is identified by Lot numbers 6109469 and 6109470, with an expiration date of 10/2016. The NDC for the product is 63323-351-20.
The recall was initiated because the product failed impurities and degradation specifications, specifically resulting in out-of-specification results for color, impurity, and degradation. The agency has classified this recall as Class II.
The affected vials were distributed nationwide, including Hawaii and Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 7,593
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 #: 6109469
- 6109470
- Exp 10/2016
UPCs (1)
- 0363323351205
Distribution
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