Cardinal Health Recalls Tramadol Hydrochloride Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 86 bottles of Tramadol Hydrochloride 100mg tablets due to intermittent exposure to temperature excursions during storage.
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 2/5 (Moderate).
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, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a CGMP deviation (temperature excursion) without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 86 bottles of Tramadol Hydrochloride Tablets USP 100mg, 100-count bottles. The product is prescription-only and was manufactured by Rubicon Research Private Limited in India. The recall is associated with the NDC 52817-0196-10 and the code 200340H1.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.
The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for the specific NDC and code listed above. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 86
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)
- 200340H1
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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