NuVision Pharmacy Recalls HCG Vials Due to Sterility Assurance Concerns
NuVision Pharmacy is recalling 285 vials of HCG (Lyophilized) nationwide due to a lack of sterility assurance identified during an FDA inspection.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
NuVision Pharmacy, Inc. is recalling 285 vials of HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial. The product was compounded by NuVision Pharmacy in Dallas, TX, and distributed nationwide.
The recall was initiated due to a lack of sterility assurance and concerns associated with quality control processes identified during an FDA inspection. The affected lots are N06252012@6 (Exp 6/25/13), N01042013@15 (Exp 1/29/14), and N05072012@3 (Exp 2/1/15).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
- Manufacturer
- NuVision Pharmacy, Inc.
- Hazard
- Affected units
- 285
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 (3)
- Lot #s: N06252012@6 Exp 6/25/13
- N01042013@15 Exp 1/29/14
- N05072012@3 Exp 2/1/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by NuVision Pharmacy, 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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