Why it was recalled
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product description
L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Lot numbers, UPCs & expiration codes
Lot #: a) L-Glut-100 mg-30 mL: 20130213-D, Exp 5/13/2013; b) L-Glut-200 mg/30 mL: 20130318-J, Exp 6/18/2013; 20130301-C, Exp 6/1/2013 ; d) L-Glutathione-200-30 mL, 30 mL: 20130205-A 5/5/2013
Where it was sold
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-378-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 10, 2013
- FDA report date
- May 22, 2013
- Quantity
- 430 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
Original FDA data
Every field from FDA enforcement report D-378-2013, exactly as published.
Show all FDA fields
- City
- Henderson
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 64879
- Address
- 1850 Whitney Mesa Dr
- Address (line 2)
- Suite 180
- Code information
- Lot #: a) L-Glut-100 mg-30 mL: 20130213-D, Exp 5/13/2013; b) L-Glut-200 mg/30 mL: 20130318-J, Exp 6/18/2013; 20130301-C, Exp 6/1/2013 ; d) L-Glutathione-200-30 mL, 30 mL: 20130205-A 5/5/2013
- Postal code
- 89014-2091
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-378-2013
- Classification
- Class II
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Product quantity
- 430 vials
- Termination date
- Mar 21, 2014
- Reason for recall
- Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 10, 2013
- Initial firm notification
- Press Release
- Center classification date
- May 16, 2013