Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Reported: April 12, 2023 Initiated: March 20, 2023 #D-0491-2023
Product Description
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Reason for Recall
cGMP Deviations
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- a) 3,497 bottles, b) 729 bottles
- Distribution
- RemedyRepack distributed product to consignees nationwide within the United States
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.. Recalled by RemedyRepack Inc.. Units affected: a) 3,497 bottles, b) 729 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-0491-2023.
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