Medications & Supplements/Prescription Drugs

Direct Rx Prescription Tablets Recalled Due to Manufacturing Deviations

Agency Publication Date: March 24, 2023

Summary

Direct Rx is recalling approximately 592 bottles of various prescription medications, including Montelukast Sodium, Finasteride, Ropinirole, Glimepiride, and Simvastatin. The recall was initiated because of manufacturing deviations that did not meet standard safety and quality requirements (cGMP). No injuries or incidents have been reported in connection with these products, which were distributed nationwide to authorized pharmacies.

Risk

The medications were produced in a manner that deviated from current Good Manufacturing Practice (cGMP) standards, which could potentially affect the quality, purity, or potency of the drugs. Using medication that does not meet these rigorous standards may lead to reduced treatment effectiveness or unexpected side effects.

What You Should Do

This recall affects various prescription medications packaged and distributed by Direct Rx, including Montelukast Sodium (10 mg), Finasteride (5 mg), Ropinirole (0.25 mg and 1 mg), Glimepiride (1 mg, 2 mg, and 4 mg), and Simvastatin (5 mg, 10 mg, 20 mg, and 40 mg).
Check your prescription bottle for the Direct Rx label and locate the drug name, dosage strength, and NDC number printed on the packaging.
Identify your specific lot number and expiration date on the bottle; affected lot numbers include a wide range of codes such as 20JU2211, 19AU2205, and 03JA2209. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Direct Rx for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Montelukast Sodium Tablets, USP, 10 mg (30 and 90-count bottles)

Variants: 10 mg, Tablets

Lot Numbers:

20JU2211 (Exp 5/31/2024)

25JU2128 (Exp 12/31/2023)

13SE2132 (Exp 12/31/2023)

25JU2133 (Exp 12/31/2023)

16JU2127 (Exp 12/31/2023)

18MY2126 (Exp 12/31/2023)

10JU2111 (Exp 12/31/2023)

14SE2111 (Exp 1/31/2024)

14JY2115 (Exp 1/31/2024)

25OC2113 (Exp 2/29/2024)

21SE2227 (Exp 2/29/2024)

10DE2123 (Exp 3/31/2024)

22NO2115 (Exp 3/31/2024)

21JA2202 (Exp 4/30/2024)

29DE2110 (Exp 4/30/2024)

28FE2227 (Exp 4/30/2024)

06JU2208 (Exp 5/31/2024)

30MA2229 (Exp 5/31/2024)

30AU2216 (Exp 6/30/2024)

23NO2203 (Exp 6/30/2024)

14DE2216 (Exp 7/31/2025)

12JA2305 (Exp 7/31/2025)

NDC:

61919-0009-30

61919-0009-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Finasteride, USP, 5 mg Tablets (90-count bottle)

Variants: 5 mg, Tablets

Lot Numbers:

19AU2205 (Exp 12/31/24)

12OC2211 (Exp 12/31/24)

NDC:

61919-0733-90

Packaged and Distributed By: Direct Rx

Product: Ropinirole, USP, 0.25 mg Tablets (30-count bottle)

Variants: 0.25 mg, Tablets

Lot Numbers:

21JU2210 (Exp 7/31/23)

NDC:

72189-0364-30

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Ropinirole, USP, 1 mg Tablets (30-count bottle)

Variants: 1 mg, Tablets

Lot Numbers:

22JU2216 (Exp 8/31/23)

NDC:

72189-0364-30

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Glimepiride, USP, 1 mg Tablets (30 and 90-count bottles)

Variants: 1 mg, Tablets

Lot Numbers:

07MA2208 (Exp 5/31/2024)

09AU2128 (Exp 1/31/2024)

28JY2102 (Exp 1/31/2024)

06AU2103 (Exp 1/31/2024)

03JA2210 (Exp 1/31/2024)

14JY2114 (Exp 1/31/2024)

05NO2106 (Exp 2/29/2024)

13OC2118 (Exp 2/29/2024)

08DE2121 (Exp 2/29/2024)

NDC:

61919-0723-30

61919-0723-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Glimepiride, USP, 2 mg Tablets (30 and 90-count bottles)

Variants: 2 mg, Tablets

Lot Numbers:

21JU2112 (Exp 9/30/2023)

22DE2113 (Exp 1/31/2024)

27JA2235 (Exp 3/31/2024)

05AP2224 (Exp 7/31/2024)

06AU2104 (Exp 1/31/2024)

08JU2215 (Exp 9/30/2024)

209AU2109 (Exp 1/31/2024)

15JU2113 (Exp 9/30/2023)

21FE2217 (Exp 4/30/2024)

21OC2115 (Exp 2/29/2024)

23JY2144 (Exp 1/31/2024)

25JU2124 (Exp 9/30/2023)

29AP2219 (Exp 7/31/2024)

07DE2128 (Exp 3/31/2024)

NDC:

61919-0488-30

61919-0448-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Glimepiride, USP, 4 mg Tablets (30 and 90-count bottles)

Variants: 4 mg, Tablets

Lot Numbers:

13DE2111 (Exp 3/31/2024)

17NO2116 (Exp 1/31/2024)

27JA2234 (Exp 4/30/2024)

02MA2218 (Exp 6/30/2024)

12MY2211 (Exp 7/31/2024)

13JY2107 (Exp 10/31/2023)

15AP2221 (Exp 7/31/2024)

17AU2110 (Exp 10/31/2023)

20SE2108 (Exp 10/31/2023)

23JU2115 (Exp 10/31/2023)

28JY2101 (Exp 10/31/2023)

30JY2101 (Exp 10/31/2023)

05JA2212 (Exp 3/31/2024)

13DE2130 (Exp 3/31/2024)

21OC2111 (Exp 1/31/2024)

17NO2116 (Exp 3/31/2024)

NDC:

61919-0250-30

61919-0250-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Simvastatin, USP, 5 mg Tablets (90-count bottle)

Variants: 5 mg, Tablets

Lot Numbers:

03JA2209 (Exp 6/30/23)

28FE2225 (Exp 6/30/23)

28AP2211 (Exp 6/30/23)

07AP2203 (Exp 6/30/23)

NDC:

61919-0710-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Simvastatin, USP, 10 mg Tablets (30 and 90-count bottles)

Variants: 10 mg, Tablets

Lot Numbers:

05AU2206 (Exp 10/31/23)

30MA2213 (Exp 6/30/23)

10DE2124 (Exp 3/31/23)

15MA2224 (Exp 5/32/23)

27JA2229 (Exp 3/31/23)

NDC:

61919-0688-30

61919-0688-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534. Expiry 5/32/23 transcribed verbatim as listed in source.

Product: Simvastatin, USP, 20 mg Tablets (30 and 90-count bottles)

Variants: 20 mg, Tablets

Lot Numbers:

09JA2312 (Exp 2/28/2025)

22OC2111 (Exp 1/31/2023)

13OC2120 (Exp 3/31/2023)

16JY2104 (Exp 12/31/2023)

09AU2125 (Exp 1/31/2024)

28JY2125 (Exp 1/31/2024)

23SE2115 (Exp 3/31/2024)

07JA2211 (Exp 5/31/2024)

27JA2214 (Exp 5/31/2024)

15AP2224 (Exp 6/30/2024)

24MA2221 (Exp 6/30/2024)

16AU2214 (Exp 6/30/2024)

NDC:

61919-0446-30

61919-0446-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Simvastatin, USP, 40 mg Tablets (90-count bottle)

Variants: 40 mg, Tablets

Lot Numbers:

28AP2212 (Exp 7/31/2024)

24MA2230 (Exp 7/31/2024)

11JA2203 (Exp 3/31/2023)

02FE2217 (Exp 2/28/2023)

10DE2126 (Exp 2/28/2023)

25MA2201 (Exp 5/31/2023)

28FE2230 (Exp 5/31/2023)

NDC:

61919-0431-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91921

Status: Resolved

Manufacturer: Direct Rx

Sold By: Authorized Pharmacies; Direct Rx

Manufactured In: United States

Units Affected: 11 products (90 count: 495 bottles; 30 count: 13 bottles; 19 bottles; 9 bottles; 4 bottles; 30 count: 4 bottles; 90 count: 172 bottles; 30 count: 12 bottles; 90 count: 253 bottles; 30 count: 7 bottles; 90 count: 395 bottles; 51 bottles; 30 count: 6 bottles; 90 count: 106 bottles; 30 count: 5 bottles; 90 count: 53 bottles; 269 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects various prescription medications packaged and distributed by Direct Rx, including Montelukast Sodium (10 mg), Finasteride (5 mg), Ropinirole (0.25 mg and 1 mg), Glimepiride (1 mg, 2 mg, and 4 mg), and Simvastatin (5 mg, 10 mg, 20 mg, and 40 mg).

Check your prescription bottle for the Direct Rx label and locate the drug name, dosage strength, and NDC number printed on the packaging.

Identify your specific lot number and expiration date on the bottle; affected lot numbers include a wide range of codes such as 20JU2211, 19AU2205, and 03JA2209. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Direct Rx for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Montelukast Sodium Tablets, USP, 10 mg (30 and 90-count bottles)

Variants: 10 mg, Tablets

Lot Numbers:

20JU2211 (Exp 5/31/2024)

25JU2128 (Exp 12/31/2023)

13SE2132 (Exp 12/31/2023)

25JU2133 (Exp 12/31/2023)

16JU2127 (Exp 12/31/2023)

18MY2126 (Exp 12/31/2023)

10JU2111 (Exp 12/31/2023)

14SE2111 (Exp 1/31/2024)

14JY2115 (Exp 1/31/2024)

25OC2113 (Exp 2/29/2024)

21SE2227 (Exp 2/29/2024)

10DE2123 (Exp 3/31/2024)

22NO2115 (Exp 3/31/2024)

21JA2202 (Exp 4/30/2024)

29DE2110 (Exp 4/30/2024)

28FE2227 (Exp 4/30/2024)

06JU2208 (Exp 5/31/2024)

30MA2229 (Exp 5/31/2024)

30AU2216 (Exp 6/30/2024)

23NO2203 (Exp 6/30/2024)

14DE2216 (Exp 7/31/2025)

12JA2305 (Exp 7/31/2025)

NDC:

61919-0009-30

61919-0009-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Finasteride, USP, 5 mg Tablets (90-count bottle)

Variants: 5 mg, Tablets

Lot Numbers:

19AU2205 (Exp 12/31/24)

12OC2211 (Exp 12/31/24)

NDC:

61919-0733-90

Packaged and Distributed By: Direct Rx

Product: Ropinirole, USP, 0.25 mg Tablets (30-count bottle)

Variants: 0.25 mg, Tablets

Lot Numbers:

21JU2210 (Exp 7/31/23)

NDC:

72189-0364-30

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Ropinirole, USP, 1 mg Tablets (30-count bottle)

Variants: 1 mg, Tablets

Lot Numbers:

22JU2216 (Exp 8/31/23)

NDC:

72189-0364-30

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Glimepiride, USP, 1 mg Tablets (30 and 90-count bottles)

Variants: 1 mg, Tablets

Lot Numbers:

07MA2208 (Exp 5/31/2024)

09AU2128 (Exp 1/31/2024)

28JY2102 (Exp 1/31/2024)

06AU2103 (Exp 1/31/2024)

03JA2210 (Exp 1/31/2024)

14JY2114 (Exp 1/31/2024)

05NO2106 (Exp 2/29/2024)

13OC2118 (Exp 2/29/2024)

08DE2121 (Exp 2/29/2024)

NDC:

61919-0723-30

61919-0723-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Glimepiride, USP, 2 mg Tablets (30 and 90-count bottles)

Variants: 2 mg, Tablets

Lot Numbers:

21JU2112 (Exp 9/30/2023)

22DE2113 (Exp 1/31/2024)

27JA2235 (Exp 3/31/2024)

05AP2224 (Exp 7/31/2024)

06AU2104 (Exp 1/31/2024)

08JU2215 (Exp 9/30/2024)

209AU2109 (Exp 1/31/2024)

15JU2113 (Exp 9/30/2023)

21FE2217 (Exp 4/30/2024)

21OC2115 (Exp 2/29/2024)

23JY2144 (Exp 1/31/2024)

25JU2124 (Exp 9/30/2023)

29AP2219 (Exp 7/31/2024)

07DE2128 (Exp 3/31/2024)

NDC:

61919-0488-30

61919-0448-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Glimepiride, USP, 4 mg Tablets (30 and 90-count bottles)

Variants: 4 mg, Tablets

Lot Numbers:

13DE2111 (Exp 3/31/2024)

17NO2116 (Exp 1/31/2024)

27JA2234 (Exp 4/30/2024)

02MA2218 (Exp 6/30/2024)

12MY2211 (Exp 7/31/2024)

13JY2107 (Exp 10/31/2023)

15AP2221 (Exp 7/31/2024)

17AU2110 (Exp 10/31/2023)

20SE2108 (Exp 10/31/2023)

23JU2115 (Exp 10/31/2023)

28JY2101 (Exp 10/31/2023)

30JY2101 (Exp 10/31/2023)

05JA2212 (Exp 3/31/2024)

13DE2130 (Exp 3/31/2024)

21OC2111 (Exp 1/31/2024)

17NO2116 (Exp 3/31/2024)

NDC:

61919-0250-30

61919-0250-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Simvastatin, USP, 5 mg Tablets (90-count bottle)

Variants: 5 mg, Tablets

Lot Numbers:

03JA2209 (Exp 6/30/23)

28FE2225 (Exp 6/30/23)

28AP2211 (Exp 6/30/23)

07AP2203 (Exp 6/30/23)

NDC:

61919-0710-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Simvastatin, USP, 10 mg Tablets (30 and 90-count bottles)

Variants: 10 mg, Tablets

Lot Numbers:

05AU2206 (Exp 10/31/23)

30MA2213 (Exp 6/30/23)

10DE2124 (Exp 3/31/23)

15MA2224 (Exp 5/32/23)

27JA2229 (Exp 3/31/23)

NDC:

61919-0688-30

61919-0688-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534. Expiry 5/32/23 transcribed verbatim as listed in source.

Product: Simvastatin, USP, 20 mg Tablets (30 and 90-count bottles)

Variants: 20 mg, Tablets

Lot Numbers:

09JA2312 (Exp 2/28/2025)

22OC2111 (Exp 1/31/2023)

13OC2120 (Exp 3/31/2023)

16JY2104 (Exp 12/31/2023)

09AU2125 (Exp 1/31/2024)

28JY2125 (Exp 1/31/2024)

23SE2115 (Exp 3/31/2024)

07JA2211 (Exp 5/31/2024)

27JA2214 (Exp 5/31/2024)

15AP2224 (Exp 6/30/2024)

24MA2221 (Exp 6/30/2024)

16AU2214 (Exp 6/30/2024)

NDC:

61919-0446-30

61919-0446-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Product: Simvastatin, USP, 40 mg Tablets (90-count bottle)

Variants: 40 mg, Tablets

Lot Numbers:

28AP2212 (Exp 7/31/2024)

24MA2230 (Exp 7/31/2024)

11JA2203 (Exp 3/31/2023)

02FE2217 (Exp 2/28/2023)

10DE2126 (Exp 2/28/2023)

25MA2201 (Exp 5/31/2023)

28FE2230 (Exp 5/31/2023)

NDC:

61919-0431-90

Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91921

Status: Resolved

Manufacturer: Direct Rx

Sold By: Authorized Pharmacies; Direct Rx

Manufactured In: United States

Distributed To: Nationwide