Pfizer Recalls Greenstone Fluconazole Oral Suspension Due to Tamper Ring Failures
Pfizer is recalling 4,155 bottles of Greenstone brand fluconazole oral suspension because some bottles have defective tamper-evident rings.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging defect (tamper-evident ring failure) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Pfizer Inc. is recalling 4,155 bottles of Greenstone brand fluconazole for Oral Suspension, Orange Flavored, 40 mg/mL. The product is a prescription-only medication distributed by Greenstone LLC in Peapack, New Jersey, and manufactured in India. The specific lot affected is # A358502 with an expiration date of 01/15.
The recall was initiated because defective tamper-evident ring failures were discovered on some of the bottles. This defect compromises the integrity of the container's tamper-evident feature. The affected product was distributed nationwide, as well as in Italy and the Republic of South Korea.
Consumers and healthcare providers who have this specific lot of fluconazole oral suspension should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- FLUCONAZOLE (FLUCONAZOLE)
- Brand
- FLUCONAZOLE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antifungal
- Affected units
- 4,155
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 # A358502
- Exp 01/15
UPCs (3)
- 0359762503015
- 0359762501516
- 0359762502919
Distribution
Distributed nationwide across the United States.
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