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Class II: temporary or reversible health riskTerminated

Olympia Compounding Pharmacy dba Olympia Pharmacy Phenylephrine 1 mg/mL Recall

Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conv…

Olympia Compounding Pharmacy dba Olympia Pharmacy · Orlando, FL

Risk level
Class II
Reported by FDA
May 4, 2022
Recall ID
D-0822-2022
Check your lot numberHow we source this data

Summary

Olympia Compounding Pharmacy dba Olympia Pharmacy recalled Phenylephrine 1 mg/mL starting Apr 4, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0822-2022 on May 4, 2022. Reason: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated. Status: Terminated.

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

Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.

Lot numbers, UPCs & expiration codes

Lot: H47030 BUD: 8/30/2022

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-0822-2022
Classification
Class II
Status
Terminated
Recall initiated
Apr 4, 2022
FDA report date
May 4, 2022
Quantity
4521 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy

Original FDA data

Every field from FDA enforcement report D-0822-2022, 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
Lot: H47030 BUD: 8/30/2022
Postal code
32835-3515
Report date
May 4, 2022
Product type
Drugs
Recall number
D-0822-2022
Classification
Class II
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Product quantity
4521 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
Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.
Distribution pattern
Distributed Nationwide in the USA
Recall initiation date
Apr 4, 2022
Initial firm notification
Letter
Center classification date
Apr 27, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0822-2022, published May 4, 2022. View the source record (openFDA) · FDA enforcement reports

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

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