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-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
Lot numbers, UPCs & expiration codes
Lots: a) E41B10 BUD: 5/10/2022; b) E41B08 BUD: 5/10/2022, I41C08 BUD: 9/8/2022, I41D08 BUD: 9/8/2022, E41C10 BUD: 5/10/2022
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-0805-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 4, 2022
- FDA report date
- May 4, 2022
- Quantity
- 2437 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-0805-2022, 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) E41B10 BUD: 5/10/2022; b) E41B08 BUD: 5/10/2022, I41C08 BUD: 9/8/2022, I41D08 BUD: 9/8/2022, E41C10 BUD: 5/10/2022
- Postal code
- 32835-3515
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0805-2022
- Classification
- Class II
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Product quantity
- 2437 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-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; 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