Why it was recalled
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Product description
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
Lot numbers, UPCs & expiration codes
141015FF, 11/15/14; 141024KK, 11/24/14; 141031CC, 12/1/14
Where it was sold
Kansas and Missouri
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-0269-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 7, 2014
- FDA report date
- Dec 3, 2014
- Quantity
- 3 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perry Drug Inc.
Original FDA data
Every field from FDA enforcement report D-0269-2015, exactly as published.
Show all FDA fields
- City
- Overland Park
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 69674
- Address
- 12200 W 106th St Ste 140
- Code information
- 141015FF, 11/15/14; 141024KK, 11/24/14; 141031CC, 12/1/14
- Postal code
- 66215-2305
- Report date
- Dec 3, 2014
- Product type
- Drugs
- Recall number
- D-0269-2015
- Classification
- Class II
- Recalling firm
- Perry Drug Inc.
- Product quantity
- 3 vials
- Termination date
- Nov 3, 2015
- Reason for recall
- Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
- Distribution pattern
- Kansas and Missouri
- Recall initiation date
- Nov 7, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 24, 2014