Food, drugs, devices › RemedyRepack Inc.
Drug recall: Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921
RemedyRepack Inc. (Indiana, PA) initiated this drug recall on 20 Mar 2023; FDA lists 14 product records under event 91980, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 19 Oct 2023. Initiation: voluntary: firm initiated. RemedyRepack Inc. has 36 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
RemedyRepack Inc., Indiana, PA.
Reason for recall
"cGMP Deviations"
Distribution
"RemedyRepack distributed product to consignees nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0490-2023 | Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03 | 3 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0491-2023 | 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. | a) 3,497 bottles, b) 729 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0492-2023 | 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. | a) 58 bottles, b) 6 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0493-2023 | 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 | a) 147 bottles, b)70 bottles, c) 3 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0494-2023 | Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00. | 17 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0495-2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00. | 399 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0496-2023 | 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 | a) 1,262 bottles, b) 95 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0497-2023 | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00 | 16 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0498-2023 | 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. | 3,426 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0499-2023 | Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00 | 3 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0500-2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00 | 132 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0501-2023 | 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. | a) 399 bottles, b)445 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0502-2023 | 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. | a) 76 bottles, b)151 bottles | Class II | Terminated | 12 Apr 2023 |
| D-0503-2023 | 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 | — | Class II | Terminated | 12 Apr 2023 |
Context
Other enforcement events for RemedyRepack Inc.
All 36 events for RemedyRepack Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP Deviations"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "RemedyRepack distributed product to consignees nationwide within the United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.