US Compounding Recalls Dapiprazole Ophthalmic Vials Due to Sterility Concerns
US Compounding Inc is recalling 2,984 bottles of compounded Dapiprazole ophthalmic vials nationwide due to deficient practices that may impact sterility assurance.
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: The recall is classified as FDA Class II and involves a lack of sterility assurance in ophthalmic products, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
US Compounding Inc is recalling 2,984 bottles of Dapiprazole (Diluent+Powder) 0.5% in 5 mL vials. These products are compounded for topical ophthalmic use and are prescription-only. The recall covers specific lot numbers with expiration dates ranging from September 2015 to November 2015.
The recall is being conducted due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for these sterile preparations. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99
- Manufacturer
- US Compounding Inc
- Category
- Drug — Compounded Ophthalmic
- Affected units
- 2,984
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 (5)
- Lot Numbers: 20150506@6 BUD: 11/28/2015
- 20150805@40 BUD: 10/31/2015
- 20151206@7 BUD: 12/5/2015
- 20151704@21 BUD: 10/10/2015
- 20152003@43 BUD: 9/12/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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