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
Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Lot numbers, UPCs & expiration codes
Lot #: a) HCG 1000u/mL: 20130319-E, Exp 5/19/2013; b) HCG 1000u/mL 10mL: 20130221-J, Exp 4/21/2013
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-370-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 10, 2013
- FDA report date
- May 22, 2013
- Quantity
- 5255 vials and syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
Original FDA data
Every field from FDA enforcement report D-370-2013, 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) HCG 1000u/mL: 20130319-E, Exp 5/19/2013; b) HCG 1000u/mL 10mL: 20130221-J, Exp 4/21/2013
- Postal code
- 89014-2091
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-370-2013
- Classification
- Class II
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Product quantity
- 5255 vials and syringes
- 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
- Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, 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