Propranolol Hydrochloride 20 mg Tablets Recalled for Temperature Storage Deviations
Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.
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 regarding storage temperature conditions. No illnesses or injuries have been reported. The hazard involves potential compromise of drug stability rather than contamination or acute safety risk, consistent with a Moderate severity classification.
Plain-English summary
Cardinal Healthcare is recalling Propranolol Hydrochloride Tablets 20 mg manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed nationwide in the United States. The recalled batch is 100023596.
The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. Specifically, products were exposed to temperatures outside the range specified on the product label during manufacturing and storage. This improper temperature exposure could potentially affect the medication's stability and effectiveness.
Patients currently taking Propranolol Hydrochloride should consult their pharmacist or healthcare provider to determine if they have the affected product. Patients should not stop taking their medication without consulting their healthcare provider, as discontinuation without medical guidance could have adverse health consequences.
The recalled product
- Product
- PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
- Brand
- PROPRANOLOL HYDROCHLORIDE
- Manufacturer
- CARDINAL HEALTHCARE
- Affected units
- 2
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 100023596
UPCs (5)
- 0369238208016
- 0369238207712
- 0369238208115
- 0369238207910
- 0369238207811
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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