Mannitol 5% Solution for injection recall: Sterility Concern
Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc.…
Why was Mannitol 5% Solution for injection recalled?
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14
- Product
- Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc.…
- Recalling firm
- John W Hollis Inc
- Quantity
- 2250 mL
- Distribution
- Nationwide
- Recall date
- June 25, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)