Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Product description
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lot numbers, UPCs & expiration codes
t20221109@41
Where it was sold
Nationwide in the USA
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-0199-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2022
- FDA report date
- Feb 1, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmacy Innovations
Original FDA data
Every field from FDA enforcement report D-0199-2023, exactly as published.
Show all FDA fields
- City
- Erie
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 91332
- Address
- 2936 W 17th St
- Code information
- t20221109@41
- Postal code
- 16505-3929
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0199-2023
- Classification
- Class II
- Recalling firm
- Pharmacy Innovations
- Termination date
- Jul 31, 2024
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 22, 2022
- Initial firm notification
- Telephone
- Center classification date
- Jan 26, 2023