FDA (Drugs) recall action 91980

RemedyRepack Inc. recalled 14 products on 2023-04-12

The FDA (Drugs) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products: 14
Announced: 2023-04-12
Critical: 0
Units: 3,996

Why these products were recalled

cGMP Deviations

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–14 of 14

ModerateFDA (Drugs)··2023-04-12
Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations
RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.
Product
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Rosuvastatin 40mg tablets recalled nationwide for manufacturing process deviations
RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.
Product
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.
Product
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
Category
Distribution
0 states
HighFDA (Drugs)··2023-04-12
Ropinirole 0.5 mg tablets recalled for manufacturing quality deviations
RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets due to manufacturing process deviations. The product was distributed nationwide within the United States.
Product
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
Category
Distribution
0 states
HighFDA (Drugs)··2023-04-12
Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations
RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.
Product
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Drug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.
Product
Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
Category
Distribution
0 states
HighFDA (Drugs)··2023-04-12
Simvastatin 10 mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. voluntarily recalled Simvastatin 10 mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lots distributed to consignees throughout the United States.
Product
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Drug Recall: Simvastatin tablets due to manufacturing deviations
RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.
Product
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Drug Recall: Atorvastatin 10 mg tablets due to manufacturing process violations
RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated March 20, 2023.
Product
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.
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations
RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.
Product
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Drug Recall: Rosuvastatin 5mg Tablets for Manufacturing Deviations
RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
Category
Distribution
0 states
HighFDA (Drugs)··2023-04-12
Doxazosin 2 mg tablets recalled for manufacturing practice deviations
RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.
Product
Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Distribution
0 states
ModerateFDA (Drugs)··2023-04-12
Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations
RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
Category
Distribution
0 states
HighFDA (Drugs)··2023-04-12
Rosuvastatin 10mg tablets recalled for manufacturing process deviations
RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets due to cGMP deviations in the manufacturing process. The recall affects 30-count and 90-count bottles distributed nationwide.
Product
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.
Category
Distribution
0 states