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Class II: temporary or reversible health riskCompleted

Olympia Compounding Pharmacy dba Olympia Pharmacy SB-6 Papaverine 30 mg/mL Phentolamine 3 Recall

SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-…

Olympia Compounding Pharmacy dba Olympia Pharmacy · Orlando, FL

Risk level
Class II
Reported by FDA
Jun 1, 2022
Recall ID
D-0901-2022
Check your lot numberHow we source this data

Summary

Olympia Compounding Pharmacy dba Olympia Pharmacy recalled SB-6 Papaverine 30 mg/mL Phentolamine 3 starting May 9, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0901-2022 on Jun 1, 2022. Reason: Lack of assurance of sterility. Status: Completed.

Why it was recalled

Lack of assurance of sterility.

Product description

SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Lot numbers, UPCs & expiration codes

Lots: L24D14, L24C14 BUD: 12/14/2022

Where it was sold

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

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-0901-2022
Classification
Class II
Status
Completed
Recall initiated
May 9, 2022
FDA report date
Jun 1, 2022
Quantity
874 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy

Original FDA data

Every field from FDA enforcement report D-0901-2022, exactly as published.

Show all FDA fields
City
Orlando
State
FL
Status
Completed
Country
United States
Event ID
90204
Address
6700 Conroy Rd Ste 155
Code information
Lots: L24D14, L24C14 BUD: 12/14/2022
Postal code
32835-3515
Report date
Jun 1, 2022
Product type
Drugs
Recall number
D-0901-2022
Classification
Class II
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Product quantity
874 vials
Reason for recall
Lack of assurance of sterility.
Voluntary / mandated
Voluntary: Firm initiated
Product description
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Distribution pattern
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Recall initiation date
May 9, 2022
Initial firm notification
Letter
Center classification date
May 25, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0901-2022, published Jun 1, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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