Pharmacy Creations Recalls Non-Sterile Ophthalmic Solution
Pharmacy Creations is recalling 50 bottles of Tropi/Cyclo/Phenyl/Tobra/Flurb sterile ophthalmic solution due to failing sterility test results.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Pharmacy Creations is recalling 50 bottles of Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution. The product is a prescription-only sterile ophthalmic solution packaged in a 1 mL dropper within a 3 mL bottle.
The recall was initiated because failing sterility results were obtained from the recalling firm's contract testing facility, indicating that the products may not be sterile. The affected lot number is 05202014@3 with an expiration date of 11/16/2014.
The product was distributed directly to patients and physicians in Florida, New Jersey, New York, and Puerto Rico. Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
- Manufacturer
- Pharmacy Creations
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 50
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 #: 05202014@3
- Exp 11/16/2014
Distribution
Part of a larger recall action
This product is one of 4 recalled by Pharmacy Creations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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