Amneal Recalls Benazepril HCl Tablets Due to Foreign Tablet Presence
Amneal Pharmaceuticals is recalling Benazepril HCl 40 mg tablets because a Promethazine HCl tablet was found in the bottle.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates a low risk of adverse health consequences, and no injuries or illnesses are reported in the source text.
Plain-English summary
Amneal Pharmaceuticals, Inc. is recalling Benazepril HCl Tablets, USP 40 mg, 100 count bottles (NDC 65162-754-10). The recall was initiated because a Promethazine HCl tablet was found in the Benazepril HCl bottle.
The affected product is Lot # BB02619A with an expiration date of 04/2021. A total of 9,720 bottles were distributed to 13 major distributors throughout the United States, who may have further distributed the product.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the distributor or pharmacy for credit. Patients should consult their healthcare provider regarding alternative medication if they have been using this specific lot.
The recalled product
- Product
- BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
- Brand
- BENAZEPRIL HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- 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 (2)
- Lot # BB02619A
- exp. date 04/2021
UPCs (4)
- 0365162751031
- 0365162753035
- 0365162754032
- 0365162752038
Distribution
Distribution scope not specified by the agency.
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