Dr. Reddy's Recalls Pravastatin Sodium Tablets Due to Impurity
Dr. Reddy's Laboratories is recalling specific lots of Pravastatin Sodium tablets because they failed impurity specifications.
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 specific illnesses or injuries are reported in the source text.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 544 bottles of Pravastatin Sodium Tablets, USP, 10 mg. The affected product is packaged in 90-count bottles (NDC 55111-229-90) and 500-count bottles (NDC 55111-229-05). The specific lot number is C700220, with an expiration date of 06/18.
The recall was initiated because the product failed impurities and degradation specifications, specifically showing high out-of-specification results for a related impurity. The product was distributed nationwide in the USA.
Consumers with this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 544
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 (3)
- Lot #: a) C700220
- Exp 06/18
- b) C700220
Distribution
Distributed nationwide across the United States.
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