Lupin Recalls Pravastatin Sodium Tablets Due to Foreign Capsule Presence
Lupin Limited is recalling specific lots of Pravastatin Sodium tablets because a foreign Duloxetine capsule was found in a bottle.
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. The hazard involves a foreign object (wrong medication) in the packaging, which is a significant quality issue but does not involve a high-risk pathogen or confirmed serious injury, fitting the Moderate category for low-risk contamination or labeling/packaging errors.
Plain-English summary
Lupin Limited is recalling Pravastatin Sodium USP, 40 mg tablets, 90-count bottles, NDC 68180-487-09. The recall is limited to Lot # G702459 with an expiration date of 2/20.
The recall was initiated due to a pharmacy complaint reporting that one Duloxetine Delayed Release Capsule, 30mg, was found inside a bottle of Pravastatin Sodium Tablets USP, 40mg. This constitutes a presence of foreign tablets/capsules.
The product was distributed throughout the United States, including Puerto Rico. Consumers should check their medication for the specific lot number and expiration date listed above. If the medication matches the recalled lot, consumers should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Lupin Limited
- Category
- Drug — Prescription Drug
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 # G702459
- Exp 2/20
UPCs (1)
- 0368180487098
Distribution
Distributed in 1 state:
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