Why it was recalled
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Product description
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
Lot numbers, UPCs & expiration codes
Lot #: 20130715@12, Exp10/13/2013
Where it was sold
Oregon and Washington
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-1019-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- 16 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Creative Compounds
Original FDA data
Every field from FDA enforcement report D-1019-2013, exactly as published.
Show all FDA fields
- City
- Wilsonville
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 66084
- Address
- 8560 Sw Salish Ln Ste 100
- Code information
- Lot #: 20130715@12, Exp10/13/2013
- Postal code
- 97070-9625
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-1019-2013
- Classification
- Class II
- Recalling firm
- Creative Compounds
- Product quantity
- 16 vials
- Termination date
- Sep 16, 2013
- Reason for recall
- Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
- Distribution pattern
- Oregon and Washington
- Recall initiation date
- Aug 23, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 10, 2013