Compounded injectable drug recall for manufacturing process monitoring deviations
Olympia Compounding Pharmacy recalls 1110 vials of SB-5 injectable (nationwide) due to failure to properly investigate environmental monitoring deviations prior to October 2021. No illnesses reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or hospitalizations. The hazard is improper investigation of manufacturing environmental monitoring, representing a potential contamination risk without confirmed harm. Theoretical risk-of-harm in injectable product meets High severity criteria.
Plain-English summary
Olympia Compounding Pharmacy is recalling 1110 vials of SB-5, a multi-dose injectable containing Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and PGE 50 mcg/mL. The product was distributed nationwide in the USA under NDC 73198-0024-10.
The recall is due to manufacturing compliance deviations. Prior to October 1, 2021, the manufacturer did not properly investigate environmental and personnel monitoring excursions that exceeded established action limits (OOAL excursions). This failure to investigate could indicate undetected environmental contamination in the manufacturing process.
The affected lots are: E48B18 (expiration 5/18/2022), E48D18 (expiration 5/18/2022), E48C18 (expiration 5/18/2022), and H24D31 (expiration 8/31/2022).
The FDA classified this as a Class II recall. No illnesses or injuries have been reported to date. Healthcare providers and patients with these lots should contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- cgmp-deviation
- environmental-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: E48B18 BUD: 5/18/2022
- E48D18 BUD
- 5/18/2022
- H24D31 BUD: 8/31/2022
- E48C18 BUD: 5/18/2022
Distribution
Distributed nationwide across the United States.
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