Macleods Pharma Recalls Tamsulosin Hydrochloride Capsules for Dissolution Failures
Macleods Pharma USA Inc is recalling Tamsulosin Hydrochloride Capsules because they failed to meet dissolution specifications.
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 typically corresponds to a moderate severity level where the product may cause temporary or medically reversible adverse health consequences, but no serious injury or death is reported.
Plain-English summary
Macleods Pharma USA Inc is recalling Tamsulosin Hydrochloride Capsules, USP 0.4 mg, because the product failed to meet dissolution specifications. The recalled product is a prescription-only medication manufactured by Macleods Pharmaceuticals Ltd in India and distributed nationwide in the United States.
The recall covers three specific bottle sizes: 100-count, 500-count, and 1000-count bottles. Specific lot numbers and expiration dates are identified in the recall notice, including lots BTP803A, BTP802A, BTP901A, and BTP802B with expiration dates ranging from July 2020 to December 2020.
Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)
- Brand
- TAMSULOSIN HYDROCHLORIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Medication
- Hazard
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 (7)
- a) BTP803A
- exp 08/2020
- b) BTP802A
- exp 07/2020
- BTP901A
- exp 12/2020
- c) BTP802B
UPCs (2)
- 0333342159106
- 0333342159113
Distribution
Distributed nationwide across the United States.
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