Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Reported: April 12, 2023 Initiated: March 20, 2023 #D-0501-2023
Product Description
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Reason for Recall
cGMP Deviations
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- a) 399 bottles, b)445 bottles
- Distribution
- RemedyRepack distributed product to consignees nationwide within the United States
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.. Recalled by RemedyRepack Inc.. Units affected: a) 399 bottles, b)445 bottles.
Why was this product recalled? ▼
cGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2023. Severity: Moderate. Recall number: D-0501-2023.
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