InvaGen Recalls Amlodipine Besylate Tablets Due to Subpotency
InvaGen Pharmaceuticals is recalling one lot of Amlodipine Besylate 10 mg tablets because the product failed to meet assay specifications at 3-month stability conditions.
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: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a subpotent drug (failure to meet assay specifications) without reported injuries or illnesses.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling one lot of Amlodipine Besylate USP 10 mg tablets, 1000-count bottles. The recalled product is prescription-only and was manufactured by Cipla Ltd. in Verna Goa, India, for Cipla USA, Inc. The specific lot number is GG80218, with an expiration date of 12/2019.
The recall was initiated because the product does not meet the product specification for the Assay test at the 3-month long-term stability condition. This indicates the tablets may be subpotent, meaning they may not contain the full labeled amount of the active ingredient.
The recall involves 2,880 bottles distributed nationwide within the United States. 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 pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 2,880
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 #: GG80218
- Exp. 12/2019
UPCs (4)
- 0369097126056
- 0369097128050
- 0369097127053
- 369097128159
Distribution
Distributed nationwide across the United States.
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