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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1,110
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.
Part of a larger recall action
This product is one of 34 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 34 products in this recall →Related recalls
Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy
See all →- HighLidocaine 2% injectable solution recalled for lack of sterility assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighCompounded pharmaceutical vials recalled due to sterility assurance failure
FDA (Drugs) · 2022-06-01
- HighOndansetron Hydrochloride vials recalled due to sterility assurance concerns
FDA (Drugs) · 2022-06-01
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- HighCompounded Injectable Drug Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- High
- HighFDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighCompounded Injectable Medication Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighCompounded Injectable Drug Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Compounded Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01