Why it was recalled
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Product description
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lot numbers, UPCs & expiration codes
All lots with Use by Date of 5/22/2016 to 8/31/2016
Where it was sold
NJ and NY
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-0208-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 28, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- ALL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Colonia Care Pharmacy
Original FDA data
Every field from FDA enforcement report D-0208-2017, exactly as published.
Show all FDA fields
- City
- Colonia
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74286
- Address
- 515 Inman Ave Ste A
- Code information
- All lots with Use by Date of 5/22/2016 to 8/31/2016
- Postal code
- 07067-1114
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0208-2017
- Classification
- Class II
- Recalling firm
- Colonia Care Pharmacy
- Product quantity
- ALL
- Termination date
- Dec 6, 2023
- Reason for recall
- Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
- Distribution pattern
- NJ and NY
- Recall initiation date
- Jul 28, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 22, 2016