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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 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.
See all 2 products in this recall →Related recalls
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