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Class II: temporary or reversible health riskTerminated

Tower Pharmacy and Compounding Phenylephrine Nasal 1% Spray Recall

Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Cr…

Tower Pharmacy and Compounding · Mission Viejo, CA

Risk level
Class II
Reported by FDA
Jan 1, 2014
Recall ID
D-384-2014
Check your lot numberHow we source this data

Summary

Tower Pharmacy and Compounding recalled Phenylephrine Nasal 1% Spray starting Nov 16, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-384-2014 on Jan 1, 2014. Reason: Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination. Status: Terminated.

Why it was recalled

Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.

Product description

Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691

Lot numbers, UPCs & expiration codes

Lot # 13603, Exp 12/13

Where it was sold

CA

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-384-2014
Classification
Class II
Status
Terminated
Recall initiated
Nov 16, 2013
FDA report date
Jan 1, 2014
Quantity
2 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Tower Pharmacy and Compounding

Original FDA data

Every field from FDA enforcement report D-384-2014, exactly as published.

Show all FDA fields
City
Mission Viejo
State
CA
Status
Terminated
Country
United States
Event ID
66889
Address
26732 Crown Valley Parkway
Code information
Lot # 13603, Exp 12/13
Postal code
92691
Report date
Jan 1, 2014
Product type
Drugs
Recall number
D-384-2014
Classification
Class II
Recalling firm
Tower Pharmacy and Compounding
Product quantity
2 Bottles
Termination date
Jan 13, 2014
Reason for recall
Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
Distribution pattern
CA
Recall initiation date
Nov 16, 2013
Initial firm notification
Letter
Center classification date
Dec 20, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-384-2014, published Jan 1, 2014. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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