The Recall Desk
ModerateFDA (Drugs)·D-1038-2017·Announced 2017-08-09

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.

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 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.

Related recalls

Same brand · PRAVASTATIN SODIUM

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · impurity

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