Upsher Smith Recalls Propranolol Hydrochloride Capsules for Dissolution Failure
Upsher Smith Laboratories is recalling 60 bottles of Propranolol Hydrochloride Extended-release Capsules, 80 mg, due to failed dissolution test requirements.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a potential lack of efficacy.
Plain-English summary
Upsher Smith Laboratories, Inc. is recalling 60 bottles of Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg. The product is identified by NDC 0245-0085-11, Lot #308198, and an expiration date of 03/2014.
The recall was initiated because the product failed dissolution test requirements. This means the capsules may not release the medication as intended, potentially affecting the drug's efficacy.
The affected product was distributed in Florida and New Jersey. Consumers who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
- Manufacturer
- Upsher Smith Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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 (2)
- Lot #308198
- Expiration Date is 03/2014
Distribution
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