Why it was recalled
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Product description
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .
Lot numbers, UPCs & expiration codes
Lots: a) D41412 BUD: 4/22/2022, E41F10 BUD: 5/10/2022, E41G10 BUD: 5/10/2022, F24D21 BUD: 6/21/2022 ; b) D41512 BUD: 4/12/2022; c) F42B21 BUD: 6/21/2022, H42B03 BUD: 8/3/2022, H42C03 BUD: 8/3/2022
Where it was sold
Distributed 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-0799-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 4, 2022
- FDA report date
- May 4, 2022
- Quantity
- 6916 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-0799-2022, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89938
- Address
- 6700 Conroy Rd Ste 155
- Code information
- Lots: a) D41412 BUD: 4/22/2022, E41F10 BUD: 5/10/2022, E41G10 BUD: 5/10/2022, F24D21 BUD: 6/21/2022 ; b) D41512 BUD: 4/12/2022; c) F42B21 BUD: 6/21/2022, H42B03 BUD: 8/3/2022, H42C03 BUD: 8/3/2022
- Postal code
- 32835-3515
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0799-2022
- Classification
- Class II
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Product quantity
- 6916 vials
- Termination date
- Jun 17, 2024
- Reason for recall
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Apr 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 27, 2022