Specialty Medicine Compounding Pharmacy: Compounded Sterile Products Recalled for Potential Contamination

Agency Publication Date: February 3, 2014

Summary

Specialty Medicine Compounding Pharmacy is recalling 433 units of various unexpired sterile human and veterinary compounded medications distributed between July 1, 2013, and October 19, 2013. The recall was initiated after floating particulate matter was discovered in a sterile 50% dextrose product, suggesting a breakdown in sterility. These products were distributed to veterinary clinics and individual pet owners in Michigan.

Risk

If products intended to be sterile are contaminated with microbes or foreign particles, patients and animals are at risk for serious, potentially life-threatening infections and inflammatory reactions at the site of injection or application.

What You Should Do

Check your medication labels for the following products: AMIKACIN SULFATE-PF, BUPRENORPHINE HCL, CYCLOSPORIN MCT, DESMOPRESSIN ACETATE, DOXYCYCLINE-OS, IDOXURIDINE, PHENOBARBITAL SODIUM, TACROLIMUS (Ointment or Solution), or XYLAZINE.
Identify affected products by checking for these specific lot numbers and 'Best By' dates: Lot t10162013@20 (10/30/2013), Lot 10112013@2 (11/10/2013), Lots t08142013@42, t07022013@29, t07242013@27, t08282013@28, t10032013@10, t08142013@36, Lot 09132013@4, Lot t09182013@39, Lot t09032013@21, Lot t07242013@22, Lot 08092013@23, Lot t08022013@17, Lot 08192013@28, Lots 08222013@17, t09052013@14, t08272013@17, t09162013@20, t09262013@6, t09302013@31, t10092013@14, Lot 08122013@39, Lot t10092013@15, Lot t07092013@24, and Lot t08212013@17.
Stop using these products immediately and set them aside in a safe place.
Contact your healthcare provider or veterinarian immediately if you or your pet have experienced any problems that may be related to using these medications.
Return any unused product to your pharmacy or the place of purchase for a refund and contact Specialty Medicine Compounding Pharmacy for further instructions.
For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

Drug product return and refund

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

Affected Products

Product: AMIKACIN SULFATE*-PF 250MG/ML INJECTABLE (20.166 mls)

Model:

Recall #: V-042-2014

Lot Numbers:

t10162013@20 (Best By 10/30/2013)

Date Ranges: Best By 10/30/2013

Product: BUPRENORPHINE* HCL 0.6MG/ML INJECTABLE (10 ml)

Model:

Recall #: V-043-2014

Lot Numbers:

10112013@2 (Best By 11/10/2013)

Date Ranges: Best By 11/10/2013

Product: CYCLOSPORIN* MCT 0.2%, 1%, or 2% OPHTHALMIC (140 mls)

Model:

Recall #: V-044-2014

Lot Numbers:

t08142013@42 (Exp 2/10/2014)

t07022013@29 (Exp 12/29/2013)

t07242013@27 (Exp 1/20/2014)

t08282013@28 (Exp 2/24/2014)

t10032013@10 (Exp 4/1/2014)

t08142013@36 (Exp 2/10/2014)

Date Ranges: Best By 12/29/2013 - 4/1/2014

Product: DESMOPRESSIN ACETATE* (0.01%, 0.0125%, 0.02%) SOLUTION (48 mls)

Model:

Recall #: V-045-2014

Lot Numbers:

09132013@4 (Exp 12/12/2013)

t09182013@39 (Exp 12/17/2013)

t09032013@21 (Exp 12/2/2013)

t07242013@22 (Exp 10/22/2013)

Date Ranges: Best By 10/22/2013 - 12/17/2013

Product: DOXYCYCLINE-OS 100MG/ML VET LIQUID

Model:

Recall #: V-046-2014

Lot Numbers:

08092013@23 (Best By 2/5/2014)

Date Ranges: Best By 2/5/2014

Product: IDOXURIDINE* OPHTHALMIC 0.1% SOLUTION (15 ml)

Model:

Recall #: V-047-2014

Lot Numbers:

t08022013@17 (Best By 9/1/2013)

Date Ranges: Best By 9/1/2013

Product: PHENOBARBITAL SODIUM* 65MG/ML INJECTABLE (10 ml)

Model:

Recall #: V-048-2014

Lot Numbers:

08192013@28 (Best By 11/17/2013)

Date Ranges: Best By 11/17/2013

Product: TACROLIMUS (VET)* 0.03% or 0.02% OPHTH SOL (70.5 mls)

Model:

Recall #: V-049-2014

Lot Numbers:

08222013@17 (Exp 10/21/2013)

t09052013@14 (Exp 11/4/2013)

t08272013@17 (Exp 10/26/2013)

t09162013@20 (Exp 11/15/2013)

t09262013@6 (Exp 11/25/2013)

t09302013@31 (Exp 11/29/2013)

t10092013@14 (Exp 12/8/2013)

Date Ranges: Best By 10/21/2013 - 12/8/2013

Product: TACROLIMUS OINTMENT 0.03% OPHTHALMIC (8.5 ml)

Model:

Recall #: V-050-2014

Lot Numbers:

08122013@39 (Exp 2/8/2014)

t10092013@15 (Exp 4/7/2014)

Date Ranges: Best By 2/8/2014 - 4/7/2014

Product: TACROLIMUS* (VET) MCT 0.02% OPHTH SOL (10 ml)

Model:

Recall #: V-051-2014

Lot Numbers:

t07092013@24 (Best By 9/7/2013)

Date Ranges: Best By 9/7/2013

Product: XYLAZINE* (VET) 100MG/ML INJECTABLE (100 mls)

Model:

Recall #: V-052-2014

Lot Numbers:

t08212013@17 (Best By 11/20/2013)

Date Ranges: Best By 11/20/2013

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66636

Status: Resolved

Manufacturer: Specialty Medicine Compounding Pharmacy

Sold By: Vet clinics; Specialty Medicine Compounding Pharmacy

Manufactured In: United States

Units Affected: 10 products (20.166 mls; 10 ml; 140 mls; 48 mls; 15 ml; 10 ml; 70.5 mls; 8.5 ml; 10 ml; 100 mls)

Distributed To: Michigan

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

Check your medication labels for the following products: AMIKACIN SULFATE-PF, BUPRENORPHINE HCL, CYCLOSPORIN MCT, DESMOPRESSIN ACETATE, DOXYCYCLINE-OS, IDOXURIDINE, PHENOBARBITAL SODIUM, TACROLIMUS (Ointment or Solution), or XYLAZINE.

Identify affected products by checking for these specific lot numbers and 'Best By' dates: Lot t10162013@20 (10/30/2013), Lot 10112013@2 (11/10/2013), Lots t08142013@42, t07022013@29, t07242013@27, t08282013@28, t10032013@10, t08142013@36, Lot 09132013@4, Lot t09182013@39, Lot t09032013@21, Lot t07242013@22, Lot 08092013@23, Lot t08022013@17, Lot 08192013@28, Lots 08222013@17, t09052013@14, t08272013@17, t09162013@20, t09262013@6, t09302013@31, t10092013@14, Lot 08122013@39, Lot t10092013@15, Lot t07092013@24, and Lot t08212013@17.

Stop using these products immediately and set them aside in a safe place.

Contact your healthcare provider or veterinarian immediately if you or your pet have experienced any problems that may be related to using these medications.

Return any unused product to your pharmacy or the place of purchase for a refund and contact Specialty Medicine Compounding Pharmacy for further instructions.

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

Affected Products

Product: AMIKACIN SULFATE*-PF 250MG/ML INJECTABLE (20.166 mls)

Model:

Recall #: V-042-2014

Lot Numbers:

t10162013@20 (Best By 10/30/2013)

Date Ranges: Best By 10/30/2013

Product: BUPRENORPHINE* HCL 0.6MG/ML INJECTABLE (10 ml)

Model:

Recall #: V-043-2014

Lot Numbers:

10112013@2 (Best By 11/10/2013)

Date Ranges: Best By 11/10/2013

Product: CYCLOSPORIN* MCT 0.2%, 1%, or 2% OPHTHALMIC (140 mls)

Model:

Recall #: V-044-2014

Lot Numbers:

t08142013@42 (Exp 2/10/2014)

t07022013@29 (Exp 12/29/2013)

t07242013@27 (Exp 1/20/2014)

t08282013@28 (Exp 2/24/2014)

t10032013@10 (Exp 4/1/2014)

t08142013@36 (Exp 2/10/2014)

Date Ranges: Best By 12/29/2013 - 4/1/2014

Product: DESMOPRESSIN ACETATE* (0.01%, 0.0125%, 0.02%) SOLUTION (48 mls)

Model:

Recall #: V-045-2014

Lot Numbers:

09132013@4 (Exp 12/12/2013)

t09182013@39 (Exp 12/17/2013)

t09032013@21 (Exp 12/2/2013)

t07242013@22 (Exp 10/22/2013)

Date Ranges: Best By 10/22/2013 - 12/17/2013

Product: DOXYCYCLINE-OS 100MG/ML VET LIQUID

Model:

Recall #: V-046-2014

Lot Numbers:

08092013@23 (Best By 2/5/2014)

Date Ranges: Best By 2/5/2014

Product: IDOXURIDINE* OPHTHALMIC 0.1% SOLUTION (15 ml)

Model:

Recall #: V-047-2014

Lot Numbers:

t08022013@17 (Best By 9/1/2013)

Date Ranges: Best By 9/1/2013

Product: PHENOBARBITAL SODIUM* 65MG/ML INJECTABLE (10 ml)

Model:

Recall #: V-048-2014

Lot Numbers:

08192013@28 (Best By 11/17/2013)

Date Ranges: Best By 11/17/2013

Product: TACROLIMUS (VET)* 0.03% or 0.02% OPHTH SOL (70.5 mls)

Model:

Recall #: V-049-2014

Lot Numbers:

08222013@17 (Exp 10/21/2013)

t09052013@14 (Exp 11/4/2013)

t08272013@17 (Exp 10/26/2013)

t09162013@20 (Exp 11/15/2013)

t09262013@6 (Exp 11/25/2013)

t09302013@31 (Exp 11/29/2013)

t10092013@14 (Exp 12/8/2013)

Date Ranges: Best By 10/21/2013 - 12/8/2013

Product: TACROLIMUS OINTMENT 0.03% OPHTHALMIC (8.5 ml)

Model:

Recall #: V-050-2014

Lot Numbers:

08122013@39 (Exp 2/8/2014)

t10092013@15 (Exp 4/7/2014)

Date Ranges: Best By 2/8/2014 - 4/7/2014

Product: TACROLIMUS* (VET) MCT 0.02% OPHTH SOL (10 ml)

Model:

Recall #: V-051-2014

Lot Numbers:

t07092013@24 (Best By 9/7/2013)

Date Ranges: Best By 9/7/2013

Product: XYLAZINE* (VET) 100MG/ML INJECTABLE (100 mls)

Model:

Recall #: V-052-2014

Lot Numbers:

t08212013@17 (Best By 11/20/2013)

Date Ranges: Best By 11/20/2013

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66636

Status: Resolved

Manufacturer: Specialty Medicine Compounding Pharmacy

Sold By: Vet clinics; Specialty Medicine Compounding Pharmacy

Manufactured In: United States

Units Affected: 10 products (20.166 mls; 10 ml; 140 mls; 48 mls; 15 ml; 10 ml; 70.5 mls; 8.5 ml; 10 ml; 100 mls)

Distributed To: Michigan