Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Product description
C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Lot numbers, UPCs & expiration codes
Lot #: 070819B, BUD 08/07/19
Where it was sold
Patient Specific Prescriptions in NJ
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-0015-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2019
- FDA report date
- Oct 9, 2019
- Quantity
- 1 droptainer bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Colonia Care Pharmacy
Original FDA data
Every field from FDA enforcement report D-0015-2020, exactly as published.
Show all FDA fields
- City
- Colonia
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83427
- Address
- 515 Inman Ave Ste A
- Code information
- Lot #: 070819B, BUD 08/07/19
- Postal code
- 07067-1114
- Report date
- Oct 9, 2019
- Product type
- Drugs
- Recall number
- D-0015-2020
- Classification
- Class II
- Recalling firm
- Colonia Care Pharmacy
- Product quantity
- 1 droptainer bottle
- Termination date
- Apr 5, 2023
- Reason for recall
- Lack of Assurance of Sterility: product sterility cannot be guaranteed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Distribution pattern
- Patient Specific Prescriptions in NJ
- Recall initiation date
- Jul 24, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 1, 2019