Tower Pharmacy Recalls Phenylephrine Nasal Spray Due to Microbial Contamination
Tower Pharmacy is recalling Phenylephrine Nasal Spray 1% due to possible microbial contamination. The affected product is for office use and was distributed in California.
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: The recall involves a risk-of-harm product (microbial contamination) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Tower Pharmacy and Compounding is recalling Phenylephrine Nasal Spray 1% in 480 mL bottles. The recall is being conducted because of possible microbial contamination of the non-sterile product.
The affected product is designated for office use. It was distributed in California. The specific lot number is 13603, and the expiration date is 12/13.
Consumers and healthcare providers should stop using the affected product and contact Tower Pharmacy and Compounding for further instructions or a refund.
The recalled product
- Product
- Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
- Manufacturer
- Tower Pharmacy and Compounding
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 2
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 (2)
- Lot # 13603
- Exp 12/13
Distribution
Distributed in 1 state:
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