US Compounding Recalls Pilocarpine Ophthalmic Drops Due to Sterility Concerns
US Compounding Inc is recalling specific lots of Pilocarpine (1/16%) Ophthalmic drops because deficient practices may have impacted 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, which corresponds to a Severe severity score (4) under the rubric, as it involves a potential health risk (sterility failure) that could lead to serious temporary or medically reversible health consequences.
Plain-English summary
US Compounding Inc is recalling two bottles of Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottles, which are prescription-only. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide.
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 all sterile preparations within their expiry dates.
Affected lots include Lot Code 20152406@3 with a best-use-by date of 9/12/2015, and Lot Code 20153108@16 with a best-use-by date of 11/29/2015. Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- 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 Code: 20152406@3 BUD: 9/12/2015
- 20153108@16 BUD: 11/29/2015
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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