Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 106 vials of a compounded injectable product due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Wells Pharmacy Network LLC is recalling 106 vials of a compounded injectable product containing MIC/B12/CAR/CHR/LYS/DMG. The product is a 30 mL vial prepared by Wells Pharmacy in Ocala, Florida.
The recall was initiated due to a lack of assurance of sterility. The affected product was prepared between February 22, 2016, and September 14, 2016, and is within its expiry date. Specific known lot codes include 06292016@10, 08092016@19, and 08232016@5.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL Injectable, 30 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 106
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 (4)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 06292016@10
- 08092016@19
- 08232016@5.
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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