Teva Recalls Propranolol Hydrochloride Tablets Due to Weight Specification Failures
Teva Pharmaceuticals is recalling specific lots of Propranolol Hydrochloride 10 mg tablets because some may not meet weight 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 involves a temporary or medically reversible adverse health consequence. The hazard is a failure to meet weight specifications, which is a quality control issue rather than a direct contamination or structural defect.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling certain lots of Propranolol Hydrochloride Tablets, USP, 10 mg. The recall is due to the potential that some tablets do not conform to weight specifications.
The affected product is sold in 1,000-count bottles and is manufactured in the Czech Republic by Teva Czech Industries, sro. The specific lots involved are 6A301029 (Expiration 1/2016) and 6A303025 (Expiration 3/2016). The NDC number for the product is 50111-467-03.
The recall covers 9,003 bottles distributed nationwide. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Tablets
- Affected units
- 9,003
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 (4)
- Lot #: 6A301029
- Exp 1/2016
- 6A303025
- Exp. 3/2016
Distribution
Distributed nationwide across the United States.
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