US Compounding Inc: Buprenorphine HCl Medications Recalled for Using Expired Ingredients

Agency Publication Date: July 17, 2020

Summary

US Compounding Inc. is recalling approximately 2,058 units of Buprenorphine HCl in various forms, including oral suspensions and transdermal gels. This recall was initiated because the Active Pharmaceutical Ingredient (API) was used after its manufacturer-assigned expiration date. Using expired ingredients can result in medication that is less potent or stable than required, potentially leading to ineffective treatment for the animals receiving it. These products were distributed to veterinary clinics and pharmacies in AR, FL, MN, OR, PA, and VA.

Risk

The use of an expired active ingredient may lead to decreased drug effectiveness or unforeseen chemical degradation. For animals being treated with Buprenorphine for pain management, this could result in inadequate pain relief or unexpected side effects.

What You Should Do

Locate your Buprenorphine HCl medication and check the label for the specific lot numbers and 'Beyond Use Dates' (BUD). Affected lots include: 06022020@23 (BUD 9/30/2020), 04132020@17 (BUD 7/12/2020), 04292020@2 (BUD 7/28/2020), 06122020@1 (BUD 9/10/2020), 04202020@1 (BUD 7/19/2020), 04222020@17 (BUD 7/21/2020), 05182020@15 (BUD 8/16/2020), 06092020@23 (BUD 9/7/2020), 06232020@20 (BUD 9/21/2020), 04222020@16 (BUD 7/21/2020), 05072020@16 (BUD 8/5/2020), 06152020@30 (BUD 9/13/2020), 01292020@12 (BUD 7/27/2020), 04/132020@27 (BUD 7/27/2020), 04302020@9 (BUD 9/30/2020), 05202020@4 (BUD 9/30/2020), 06112020@5 (BUD 9/30/2020), 02242020@21 (BUD 7/27/2020), 03092020@9 (BUD 7/27/2020), 03092020@16 (BUD 7/27/2020), 04132020@19 (BUD 7/27/2020), 04272020@5 (BUD 9/30/2020), 05212020@5 (BUD 8/10/2020), and 06112020@4 (BUD 9/9/2020).
Immediately stop using the medication if the lot number matches any of those listed above.
Contact your veterinarian or pharmacist to discuss alternative treatments and to report the use of the recalled product.
Return any unused portions of the medication to the pharmacy or clinic where you purchased it for a refund.
Contact US Compounding Inc. at 1270 Dons Ln, Conway, AR 72032-4753 for further instructions regarding the return of these products.
For additional questions, contact the FDA Center for Veterinary Medicine at (240) 402-7002.

Your Remedy Options

Full Refund

Refund or replacement for expired compounded medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Buprenorphine HCl 0.3 mg/mL suspension (100 mL)

Model:

NDC 3330099470

Lot Numbers:

06022020@23 (BUD 9/30/2020)

Date Ranges: 9/30/2020

Product: Buprenorphine HCl 0.3 mg/mL (chicken) suspension (100 mL)

Model:

NDC 33300984470

Lot Numbers:

04132020@17 (BUD 7/12/2020)

04292020@2 (BUD 7/28/2020)

06122020@1 (BUD 9/10/2020)

Date Ranges: 7/12/2020, 7/28/2020, 9/10/2020

Product: Buprenorphine HCl 0.3 mg/mL (flavorless) suspension (100 mL)

Model:

NDC 33300002670

Lot Numbers:

04202020@1 (BUD 7/19/2020)

04222020@17 (BUD 7/21/2020)

05182020@15 (BUD 8/16/2020)

06092020@23 (BUD 9/7/2020)

06232020@20 (BUD 9/21/2020)

Date Ranges: 7/19/2020, 7/21/2020, 8/16/2020, 9/7/2020, 9/21/2020

Product: Buprenorphine HCl 0.3 mg/mL (chicken) suspension (30 mL)

Model:

NDC 33300984406

Lot Numbers:

04222020@16 (BUD 7/21/2020)

05072020@16 (BUD 8/5/2020)

06152020@30 (BUD 9/13/2020)

Date Ranges: 7/21/2020, 8/5/2020, 9/13/2020

Product: Buprenorphine HCl Transdermal 0.3 mg/mL PLO Gel

Model:

NDC 33300900601

Lot Numbers:

01292020@12 (BUD 7/27/2020)

04/132020@27 (BUD 7/27/2020)

04302020@9 (BUD 9/30/2020)

05202020@4 (BUD 9/30/2020)

06112020@5 (BUD 9/30/2020)

Date Ranges: 7/27/2020, 9/30/2020

Product: Buprenorphine HCl Transdermal 1 mg/mL PLO Gel

Model:

NDC 33300901301

Lot Numbers:

02242020@21 (BUD 7/27/2020)

03092020@9 (BUD 7/27/2020)

03092020@16 (BUD 7/27/2020)

04132020@19 (BUD 7/27/2020)

04272020@5 (BUD 9/30/2020)

Date Ranges: 7/27/2020, 9/30/2020

Product: Buprenorphine HCl 0.6 mg/mL (chicken) suspension (60 mL)

Model:

NDC 33300901209

Lot Numbers:

05212020@5 (BUD 8/10/2020)

Date Ranges: 8/10/2020

Product: Buprenorphine HCl 0.6 mg/mL suspension (30 mL)

Model:

NDC 33300984409

Lot Numbers:

06112020@4 (BUD 9/9/2020)

Date Ranges: 9/9/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86016

Status: Resolved

Manufacturer: US Compounding Inc

Sold By: Veterinary clinics; Pharmacies

Manufactured In: United States

Units Affected: 2058 mL

Distributed To: Arkansas, Florida, Minnesota, Oregon, Pennsylvania, Virginia

Agency Last Updated: July 21, 2020

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

Summary

What You Should Do

Locate your Buprenorphine HCl medication and check the label for the specific lot numbers and 'Beyond Use Dates' (BUD). Affected lots include: 06022020@23 (BUD 9/30/2020), 04132020@17 (BUD 7/12/2020), 04292020@2 (BUD 7/28/2020), 06122020@1 (BUD 9/10/2020), 04202020@1 (BUD 7/19/2020), 04222020@17 (BUD 7/21/2020), 05182020@15 (BUD 8/16/2020), 06092020@23 (BUD 9/7/2020), 06232020@20 (BUD 9/21/2020), 04222020@16 (BUD 7/21/2020), 05072020@16 (BUD 8/5/2020), 06152020@30 (BUD 9/13/2020), 01292020@12 (BUD 7/27/2020), 04/132020@27 (BUD 7/27/2020), 04302020@9 (BUD 9/30/2020), 05202020@4 (BUD 9/30/2020), 06112020@5 (BUD 9/30/2020), 02242020@21 (BUD 7/27/2020), 03092020@9 (BUD 7/27/2020), 03092020@16 (BUD 7/27/2020), 04132020@19 (BUD 7/27/2020), 04272020@5 (BUD 9/30/2020), 05212020@5 (BUD 8/10/2020), and 06112020@4 (BUD 9/9/2020).

Immediately stop using the medication if the lot number matches any of those listed above.

Contact your veterinarian or pharmacist to discuss alternative treatments and to report the use of the recalled product.

Return any unused portions of the medication to the pharmacy or clinic where you purchased it for a refund.

Contact US Compounding Inc. at 1270 Dons Ln, Conway, AR 72032-4753 for further instructions regarding the return of these products.

For additional questions, contact the FDA Center for Veterinary Medicine at (240) 402-7002.

Affected Products

Product: Buprenorphine HCl 0.3 mg/mL suspension (100 mL)

Model:

NDC 3330099470

Lot Numbers:

06022020@23 (BUD 9/30/2020)

Date Ranges: 9/30/2020

Product: Buprenorphine HCl 0.3 mg/mL (chicken) suspension (100 mL)

Model:

NDC 33300984470

Lot Numbers:

04132020@17 (BUD 7/12/2020)

04292020@2 (BUD 7/28/2020)

06122020@1 (BUD 9/10/2020)

Date Ranges: 7/12/2020, 7/28/2020, 9/10/2020

Product: Buprenorphine HCl 0.3 mg/mL (flavorless) suspension (100 mL)

Model:

NDC 33300002670

Lot Numbers:

04202020@1 (BUD 7/19/2020)

04222020@17 (BUD 7/21/2020)

05182020@15 (BUD 8/16/2020)

06092020@23 (BUD 9/7/2020)

06232020@20 (BUD 9/21/2020)

Date Ranges: 7/19/2020, 7/21/2020, 8/16/2020, 9/7/2020, 9/21/2020

Product: Buprenorphine HCl 0.3 mg/mL (chicken) suspension (30 mL)

Model:

NDC 33300984406

Lot Numbers:

04222020@16 (BUD 7/21/2020)

05072020@16 (BUD 8/5/2020)

06152020@30 (BUD 9/13/2020)

Date Ranges: 7/21/2020, 8/5/2020, 9/13/2020

Product: Buprenorphine HCl Transdermal 0.3 mg/mL PLO Gel

Model:

NDC 33300900601

Lot Numbers:

01292020@12 (BUD 7/27/2020)

04/132020@27 (BUD 7/27/2020)

04302020@9 (BUD 9/30/2020)

05202020@4 (BUD 9/30/2020)

06112020@5 (BUD 9/30/2020)

Date Ranges: 7/27/2020, 9/30/2020

Product: Buprenorphine HCl Transdermal 1 mg/mL PLO Gel

Model:

NDC 33300901301

Lot Numbers:

02242020@21 (BUD 7/27/2020)

03092020@9 (BUD 7/27/2020)

03092020@16 (BUD 7/27/2020)

04132020@19 (BUD 7/27/2020)

04272020@5 (BUD 9/30/2020)

Date Ranges: 7/27/2020, 9/30/2020

Product: Buprenorphine HCl 0.6 mg/mL (chicken) suspension (60 mL)

Model:

NDC 33300901209

Lot Numbers:

05212020@5 (BUD 8/10/2020)

Date Ranges: 8/10/2020

Product: Buprenorphine HCl 0.6 mg/mL suspension (30 mL)

Model:

NDC 33300984409

Lot Numbers:

06112020@4 (BUD 9/9/2020)

Date Ranges: 9/9/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86016

Status: Resolved

Manufacturer: US Compounding Inc

Sold By: Veterinary clinics; Pharmacies

Manufactured In: United States

Units Affected: 2058 mL

Distributed To: Arkansas, Florida, Minnesota, Oregon, Pennsylvania, Virginia

Agency Last Updated: July 21, 2020