John W Hollis Inc Recalls Phosphatidylcholine Injection Due to Labeling Error
John W Hollis Inc is recalling 7 vials of Phosphatidylcholine Solution for Injection because the expiration date on the label is earlier than the date listed on the vial.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding expiration dates, which fits the criteria for moderate severity.
Plain-English summary
John W Hollis Inc is recalling 7 vials of Phosphatidylcholine Solution for Injection, 50 mg/mL, 50 mL Vial. The product is prescription-only and not for resale. The recall is due to a labeling error where the expiration date is earlier than the date listed on the vial.
The affected lots are Lot #41652 with an expiry of 8/2/14 and Lot #41668 with an expiry of 7/13/14. The product was distributed to Missouri, Tennessee, Mississippi, and Wisconsin.
Consumers and healthcare providers should stop using the affected product and contact John W Hollis Inc for further instructions.
The recalled product
- Product
- Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 7
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)
- Lot #: 41652
- Expiry: 8/2/14
- Lot #: 41668
- Expiry: 7/13/14
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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