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Recall Observatory FDA recall evidence

Drug product

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

D-384-2014

November 16, 2013

Class II

Product summary

Firm
Tower Pharmacy and Compounding
Event
Event 66889
Status
Terminated
Classification
Class II
Quantity
2 Bottles
Official record key
drug-enforcement:D-384-2014

Official wording

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

Code information: Lot # 13603, Exp 12/13

Distribution pattern: CA

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination