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Class II: temporary or reversible health riskTerminated

Partell Specialty Pharmacy Glutathione 200mg/mL Recall

Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S

Partell Specialty Pharmacy · Las Vegas, NV

Risk level
Class II
Reported by FDA
Apr 25, 2018
Recall ID
D-0638-2018
Check your lot numberHow we source this data

Summary

Partell Specialty Pharmacy recalled Glutathione 200mg/mL starting Mar 22, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0638-2018 on Apr 25, 2018. Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Status: Terminated.

Why it was recalled

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Product description

Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Lot numbers, UPCs & expiration codes

Lot#: 20180219@58, BUD 05/20/2018; 20180131@15, BUD 05/01/2018; 20180116@9, BUD 04/14/2018; 20180103@5, BUD 04/03/2018.

Where it was sold

NV only

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-0638-2018
Classification
Class II
Status
Terminated
Recall initiated
Mar 22, 2018
FDA report date
Apr 25, 2018
Quantity
four vials
Recall type
Voluntary: Firm initiated
Recalling firm
Partell Specialty Pharmacy

Original FDA data

Every field from FDA enforcement report D-0638-2018, exactly as published.

Show all FDA fields
City
Las Vegas
State
NV
Status
Terminated
Country
United States
Event ID
79619
Address
5835 S Eastern Ave Ste 101
Code information
Lot#: 20180219@58, BUD 05/20/2018; 20180131@15, BUD 05/01/2018; 20180116@9, BUD 04/14/2018; 20180103@5, BUD 04/03/2018.
Postal code
89119-3031
Report date
Apr 25, 2018
Product type
Drugs
Recall number
D-0638-2018
Classification
Class II
Recalling firm
Partell Specialty Pharmacy
Product quantity
four vials
Termination date
Jan 15, 2019
Reason for recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Distribution pattern
NV only
Recall initiation date
Mar 22, 2018
Initial firm notification
Letter
Center classification date
Apr 17, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0638-2018, published Apr 25, 2018. 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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