John W Hollis Recalls Papaverine, Phentolamine, and Atropine Solution Vials
John W Hollis Inc is recalling specific vials of Papaverine, Phentolamine, and Atropine solution due to an incorrect expiration date on the label.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.
Plain-English summary
John W Hollis Inc is recalling 10 mL vials of Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution. The recall is limited to Lot #1905 with an expiration date of 4/30/14. The product is prescription-only and was distributed in Missouri, Tennessee, Mississippi, and Wisconsin.
The recall was initiated because the expiration date printed on the vial is earlier than the actual expiration date of the product. This is a labeling error that does not indicate a change in the product's safety or efficacy.
Consumers and healthcare providers who have this specific lot of the medication should stop using it and contact their pharmacist or the recalling firm for instructions on how to return the product. No adverse health consequences are expected from this labeling discrepancy.
The recalled product
- Product
- Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Pharmacy Compounded
- Hazard
- Affected units
- 1
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 #: 1905
- Expiry: 4/30/14
Distribution
Part of a larger recall action
This product is one of 4 recalled by John W Hollis 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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