Spironolactone Ophthalmic Solution Recalled for Lack of Sterility Assurance
Greenpark Compounding Pharmacy is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL due to lack of assurance of sterility. The 15 mL bottles were distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a prescription ophthalmic drug with a sterility defect. Although no specific illnesses or injuries are reported in the source text, ophthalmic solutions lacking sterility assurance pose a significant risk of serious infection and eye damage. This meets the Severe criterion for Class II recalls with inherent risk of serious harm to a vulnerable anatomical site.
Plain-English summary
Prescription Labs Inc, doing business as Greenpark Compounding Pharmacy, is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL in 15 mL bottles. The recall affects approximately 350 bottles that were distributed nationwide within the United States.
The recalled product does not have assured sterility. Spironolactone Ophthalmic Solution is a prescription-only medication intended for ophthalmic (eye) use, and sterility is critical for products administered directly to the eye to prevent serious infection and complications.
The affected lot numbers are: 03012021@35, 04132021@10, 05102021@12, 06012021@28, 07012021@25, 03012021@36, 04132021@12, 05102021@11, 06012021@29, 07132021@14, 03152021@9, 06162021@21, 07132021@16, 03152021@10, 06162021@22.
Patients who have received this medication should contact their healthcare provider. Those currently using this product should stop and consult their physician regarding alternative treatment options.
The recalled product
- Product
- Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
- Manufacturer
- Prescription Labs Inc dba Greenpark
- Category
- Drug — Ophthalmic Solution
- Affected units
- 350
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 (15)
- Lots: 03012021@35
- 04132021@10
- 05102021@12
- 06012021@28
- 07012021@25
- 03012021@36
- 04132021@12
- 05102021@11
- 06012021@29
- 07132021@14
- 03152021@9
- 06162021@21
- 07132021@16
- 03152021@10
- 06162021@22
Distribution
Distributed nationwide across the United States.
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