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Class II: temporary or reversible health riskTerminated

McGuff Compounding Pharmacy Services Dimercaptopropanesulfonate Sodium Recall

Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV,…

McGuff Compounding Pharmacy Services, Inc. · Santa Ana, CA

Risk level
Class II
Reported by FDA
Feb 5, 2020
Recall ID
D-0821-2020
Check your lot numberHow we source this data

Summary

McGuff Compounding Pharmacy Services recalled Dimercaptopropanesulfonate Sodium starting Feb 14, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0821-2020 on Feb 5, 2020. Reason: Presence of Particulate Matter: Particulates observed in vials release for dispensing. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: Particulates observed in vials release for dispensing.

Product description

Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704

Lot numbers, UPCs & expiration codes

Lot #18J1081, Exp 03/10/19

Where it was sold

Prescriptions filled for patients in the following states: AK, AZ, CA, CO, DC, FL, IN, MA, MT, NC, NJ, NY, OR, SC, TX, UT, VA, WA, and WI.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0821-2020
Classification
Class II
Status
Terminated
Recall initiated
Feb 14, 2019
FDA report date
Feb 5, 2020
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
McGuff Compounding Pharmacy Services, Inc.

Original FDA data

Every field from FDA enforcement report D-0821-2020, exactly as published.

Show all FDA fields
City
Santa Ana
State
CA
Status
Terminated
Country
United States
Event ID
84622
Address
2921 W Macarthur Blvd Ste 142
Code information
Lot #18J1081, Exp 03/10/19
Postal code
92704-7944
Report date
Feb 5, 2020
Product type
Drugs
Recall number
D-0821-2020
Classification
Class II
Recalling firm
McGuff Compounding Pharmacy Services, Inc.
Termination date
Nov 20, 2023
Reason for recall
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
Distribution pattern
Prescriptions filled for patients in the following states: AK, AZ, CA, CO, DC, FL, IN, MA, MT, NC, NJ, NY, OR, SC, TX, UT, VA, WA, and WI.
Recall initiation date
Feb 14, 2019
Initial firm notification
Telephone
Center classification date
Jan 29, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0821-2020, published Feb 5, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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