John W Hollis Recalls Mannitol 5% Solution for Injection Due to Sterility Concerns
John W Hollis Inc. is recalling specific lots of Mannitol 5% Solution for injection because the products lack 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 involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
John W Hollis Inc. is voluntarily recalling 2,250 mL of Mannitol 5% Solution for injection. The affected products are compounded aseptically filled injectable solutions that contain Mannitol 50 mg, Sterile Water for Injection, and Chlorobutanol USP in 50 mL vials.
The recall is being conducted due to a lack of assurance of sterility in the compounded products. The specific lots affected are Lot 1507 (Use by 5/18/14) and Lot 1863 (Use by 7/20/14). The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected lots immediately and contact the recalling firm, John W Hollis Inc., for further instructions or to arrange for a return.
The recalled product
- Product
- Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Injectable Solution
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 1507
- Use by 5/18/14
- Lot 1863
- Use by 7/20/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 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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