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Class II: temporary or reversible health riskTerminated

Customceutical Compounding Glutathione 200mg/mL inj Recall

Glutathione 200mg/mL inj

Customceutical Compounding · Phoenix, AZ

Risk level
Class II
Reported by FDA
May 8, 2019
Recall ID
D-1255-2019
Check your lot numberHow we source this data

Summary

Customceutical Compounding recalled Glutathione 200mg/mL inj starting Apr 8, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1255-2019 on May 8, 2019. Reason: Lack of assurance of sterility for injectables and solutions intended to be sterile. Status: Terminated.

Why it was recalled

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Product description

Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Lot numbers, UPCs & expiration codes

Lot #: 02132019@25, Exp 5/14/19

Where it was sold

U.S.A. Nationwide

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-1255-2019
Classification
Class II
Status
Terminated
Recall initiated
Apr 8, 2019
FDA report date
May 8, 2019
Quantity
4 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Customceutical Compounding

Original FDA data

Every field from FDA enforcement report D-1255-2019, exactly as published.

Show all FDA fields
City
Phoenix
State
AZ
Status
Terminated
Country
United States
Event ID
82615
Address
4611 E Shea Blvd Bldg 3 Ste 180
Code information
Lot #: 02132019@25, Exp 5/14/19
Postal code
85028-4258
Report date
May 8, 2019
Product type
Drugs
Recall number
D-1255-2019
Classification
Class II
Recalling firm
Customceutical Compounding
Product quantity
4 vials
Termination date
May 19, 2023
Reason for recall
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Apr 8, 2019
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Apr 30, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1255-2019, published May 8, 2019. View the source record (openFDA) · FDA enforcement reports

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

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