Meta Pharmacy Recalls Compounded Eye Drops Due to Sterility Concerns
Meta Pharmacy Services is recalling Phenylephrine and Tropicamide compounded eye drops due to a lack of sterility assurance. The affected product was distributed to one consignee in Las Vegas.
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. According to the rubric, an FDA Class II recall involving a sterile compounded drug (where lack of sterility assurance implies a risk of serious injury or hospitalization) corresponds to a severity score of 4 (Severe).
Plain-English summary
Meta Pharmacy Services is recalling Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, due to a lack of sterility assurance. The recalled product is identified by Lot 112716SB and has an expiration date of 12/27/2016. The NDC number is 99999-0106-99.
The product is a sterile compounded drug intended for hospital or office use only and is not for resale. It is stored at room temperature. The recall involves a total quantity of 150 mL.
The affected product was distributed to one consignee in Las Vegas. Because the product is for professional medical use, consumers are unlikely to have this product in their homes. Healthcare facilities and pharmacies should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
- Manufacturer
- Meta Pharmacy Services
- Category
- Drug — Compounded Sterile Drug
- Hazard
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: 112716SB
- Exp. 12/27/2016
Distribution
Distribution scope not specified by the agency.
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