Dicyclomine Hydrochloride Tablets Recalled for Improper Storage Conditions
Cardinal Healthcare is recalling Dicyclomine Hydrochloride 20 mg tablets due to temperature exposure outside labeled storage conditions. No illnesses have been reported.
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 FDA Class II recall involves a CGMP deviation due to temperature exposure outside labeled storage conditions. No illnesses or injuries have been reported. The recall is precautionary, addressing a theoretical risk that temperature exposure may affect drug stability and efficacy.
Plain-English summary
Cardinal Healthcare is recalling Dicyclomine Hydrochloride Tablets, USP 20 mg nationwide. Batch 3197790 was exposed to temperatures outside of the product's labeled storage conditions, resulting in a Current Good Manufacturing Practice (CGMP) deviation.
Dicyclomine Hydrochloride is a prescription medication. The recalled batch (NDC 0591-0795-01) was distributed nationwide. Patients currently taking this medication should contact their pharmacy or healthcare provider to confirm whether their dispensed medication is from the recalled batch.
Healthcare providers and pharmacists should check their inventory for batch 3197790 and remove it from distribution. No illnesses or adverse events related to this recall have been reported.
The recalled product
- Product
- DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
- Brand
- DICYCLOMINE HYDROCHLORIDE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Oral Tablets
- Hazard
- temperature-exposure
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 3197790
UPCs (2)
- 0305910795016
- 0305910794019
Distribution
Distributed nationwide across the United States.
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