SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots: E48B18 BUD: 5/18/2022, E48D18 BUD; 5/18/2022, H24D31 BUD: 8/31/2022; E48C18 BUD: 5/18/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10.
Product Codes/Lot Numbers:
Lots: E48B18 BUD: 5/18/2022, E48D18 BUD; 5/18/2022, H24D31 BUD: 8/31/2022; E48C18 BUD: 5/18/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0807-2022
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