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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy: Various Injectable Drugs Recalled for Lack of Sterility Assurance

Agency Publication Date: April 6, 2020
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Summary

Innovative Compounding Pharmacy is voluntarily recalling several injectable prescription medications, including Methylcobalamin (B-12), MIC-8, Hydroxyprogesterone Caproate, Testosterone Cypionate, and a Tri-Mix solution (Alprostadil/Papaverine/Phentolamine). These products were recalled because the pharmacy cannot guarantee they are sterile, which is a critical safety requirement for any medication injected into the body. This recall affects specific lots distributed to patients in California, Maine, and Texas between November 2019 and March 2020.

Risk

Injecting a drug that is not sterile can introduce bacteria or other contaminants directly into the bloodstream or muscle tissue, which can lead to serious, life-threatening infections or localized abscesses. While no injuries have been reported to date, the lack of sterility assurance means the safety of these products cannot be confirmed.

What You Should Do

  1. Check your medication vials and packaging for the following product names: Methylcobalamin, MIC-8, Hydroxyprogesterone Caproate, Testosterone Cypionate, or Alprostadil/Papaverine/Phentolamine.
  2. Verify the lot numbers on your medication against the following affected lots: 02262020, 01032020, 01162020, 03022020, 02212020, 11152019, 12042019, 12172019, or 02282020.
  3. Immediately stop using any of the affected medications listed above.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any adverse health effects.
  5. Return any unused portions of the recalled medication to Innovative Compounding Pharmacy at 41538 Eastman Dr Ste A, Murrieta, California, 92562 or contact them at 951-304-9530 for refund instructions.
  6. For further information or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Innovative Compounding Pharmacy refund and guidance.

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

Affected Products

Product: Methylcobalamin Soln. 1000 mcg/ml (10 mL)
Model:
Recall #: D-1095-2020
Lot Numbers:
02262020@51 (Exp 05-26-2020)
01032020@53 (Exp 04-02-2020)
01162020@57 (Exp 04-15-2020)
Date Ranges: Expires after 05-26-2020, Expires after 04-02-2020, Expires after 04-15-2020
Product: MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) (10 mL)
Model:
Recall #: D-1096-2020
Lot Numbers:
03022020@64 (Exp 05-18-2020)
01032020@51 (Exp 04-02-2020)
Date Ranges: Expires after 05-18-2020, Expires after 04-02-2020
Product: Hydroxyprogesterone Caproate (BUD) 350mg/ml (4 mL)
Model:
Recall #: D-1097-2020
Lot Numbers:
02212020@2 (Exp 04-21-2020)
02262020@52 (Exp 04-26-2020)
Date Ranges: Expires after 04-21-2020, Expires after 04-26-2020
Product: Testosterone Cypionate In Sesame Oil 200mg/ml (5 mL)
Model:
Recall #: D-1098-2020
Lot Numbers:
11152019@41 (Exp 04-07-2020)
12042019@12 (Exp 04-26-2020)
12172019@9 (Exp 05-09-2020)
01032020@49 (Exp 05-26-2020)
01162020@55 (Exp 06-08-2020)
Date Ranges: Expires after 04-07-2020, Expires after 04-26-2020, Expires after 05-09-2020, Expires after 05-26-2020, Expires after 06-08-2020
Product: Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln (5 mL)
Model:
Recall #: D-1099-2020
Lot Numbers:
02282020@30 (Exp 04/28/2020)
Date Ranges: Expires after 04/28/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85351
Status: Resolved
Manufacturer: Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Sold By: Innovative Compounding Pharmacy
Manufactured In: United States
Distributed To: California, Maine, Texas

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.