Acetaminophen Oral Solution recall: CGMP Deviations
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
Why was Acetaminophen Oral Solution recalled?
CGMP Deviations: Failure to properly investigate failed microbial testing.
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: 20040A, EXP May 2022
- Product
- Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
- Recalling firm
- Plastikon Healthcare LLC
- Quantity
- 121,800 Unit Dose cups
- Distribution
- Distributed in Indiana for further distribution in the USA.
- Recall date
- May 25, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)