Why it was recalled
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Product description
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Lot numbers, UPCs & expiration codes
Lot #: 05122014@4, Exp 09/09/2014
Where it was sold
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
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-0306-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 5, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 12 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmacy Creations
Original FDA data
Every field from FDA enforcement report D-0306-2015, exactly as published.
Show all FDA fields
- City
- Randolph
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69184
- Address
- 540 Route Ten West
- Code information
- Lot #: 05122014@4, Exp 09/09/2014
- Postal code
- 07869
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0306-2015
- Classification
- Class I
- Recalling firm
- Pharmacy Creations
- Product quantity
- 12 vials
- Termination date
- Jul 6, 2015
- Reason for recall
- Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
- Distribution pattern
- Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
- Recall initiation date
- Sep 5, 2014
- Initial firm notification
- Press Release
- Center classification date
- Dec 19, 2014