Cardinal Health Recalls Rectiv Nitroglycerin Ointment Due to Temperature Excursions
Cardinal Health is recalling 31 tubes of Rectiv (nitroglycerin) ointment due to intermittent exposure to temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations involving temperature excursions, which falls under the rubric for moderate severity involving potential quality issues without reported illness.
Plain-English summary
Cardinal Health Inc. is recalling 31 tubes of Rectiv (nitroglycerin) Ointment 0.4% for intra-anal use. The product is manufactured by Pharbil Waltrop GmbH and distributed by Aptalis Pharma US, Inc. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product is identified by the code 2399070 and NDC 58914-301-80. The distribution pattern for this recall includes Florida, Georgia, and South Carolina. The agency has classified this recall as Class II.
Consumers who possess this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- RECTIV (NITROGLYCERIN)
- Brand
- RECTIV
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Ointment
- Affected units
- 31
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 (1)
- 2399070
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. 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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