InvaGen Recalls Testosterone Topical Solution Due to Defective Container
InvaGen Pharmaceuticals is recalling 1,776 bottles of Testosterone Topical Solution because defective containers may cause the actuator to function improperly, affecting dose delivery.
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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The defect is a mechanical issue with the container actuator affecting dose delivery, rather than a contamination or labeling error involving a high-risk pathogen or allergen.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling 1,776 bottles of Testosterone Topical Solution (30mg per pump actuation). The product is manufactured by Cipla Ltd in India for Cipla USA, Inc. The recall involves specific lots (GH80480 and GH80481) with an expiration date of March 2020.
The recall is being issued because the product containers are defective. Specifically, the actuator may function improperly, which can affect the delivery of the dose. The product was distributed nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Topical Solution
- Affected units
- 1,776
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 GH80480 and GH80481
- exp 3/2020
Distribution
Distributed nationwide across the United States.
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