Amoxicillin oral suspension recalled for temperature storage deviation
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension nationwide due to CGMP deviations. Products were exposed to temperatures outside their labeled storage conditions.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential product degradation from temperature exposure, which is theoretical with no confirmed adverse health effects. The recall represents a manufacturing quality issue identified during compliance review.
Plain-English summary
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension USP, 400MG/5ML (100ML when reconstituted), manufactured by Teva Cana Limited and distributed by Cardinal Healthcare. The product was exposed to temperatures outside the range specified on the product label, which constitutes a CGMP deviation. Batch 35447184A is affected.
The product has been distributed nationwide. Consumers who have this product should check the batch number on their package to confirm whether it matches the recalled batch 35447184A. If the batch number matches, do not use the product and contact a pharmacist or healthcare provider for guidance.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Oral Suspension
- Affected units
- 3
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)
- Batch 35447184A
UPCs (9)
- 0300933107051
- 0300932264014
- 0300934161731
- 0300933109055
- 0300932267015
- 0300932268012
- 0300932263017
- 0300934160734
- 0300934155730
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE 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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