Wells Pharmacy Recalls Phenylephrine HCl Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 1,968 vials of Phenylephrine HCl Injectable due to a lack of assurance of sterility. The product was 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: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility in an injectable) corresponds to a Severe rating.
Plain-English summary
Wells Pharmacy Network LLC is recalling 1,968 vials of Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial. The recall is being conducted because of a lack of assurance of sterility in the compounded product.
The affected product was prepared by Wells Pharmacy in Ocala, FL, between February 22, 2016, and September 14, 2016. The recall includes all lot codes prepared within this timeframe that are within their expiry date. Known lot codes include 03292016@3, 04202016@4, 05162016@6, 06102016@9, 07202016@44, and 08032016@38.
The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,968
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 (7)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot codes: 03292016@3
- 04202016@4
- 05162016@6
- 06102016@9
- 07202016@44
- 08032016@38
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC 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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