Acetaminophen Oral Solution recall: CGMP Deviations
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71
Why was Acetaminophen Oral Solution recalled?
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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 # 20062A, 20067A, EXP Jun. 2022; 20092A, 20093A, EXP Sep. 2022; 20101A, 21110A, EXP Oct. 2022; 20108A, EXP Nov. 2022; 21012A, EXP Jan. 2023; 21044A, 21048B, EXP Apr. 2023; 21053A, EXP May. 2023; 21063B, 21068B, EXP Jun. 2023; 21084B, EXP Jul. 2023; 21090A, EXP Aug. 2023; 21119A, EXP Nov. 2023; 21122B, EXP Dec. 2023; 22001B, 22006A, EXP Jan. 2024; 22017B, EXP Mar. 2024
- Product
- Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71
- Recalling firm
- Plastikon Healthcare LLC
- Quantity
- 848,500 cups
- Distribution
- Distributed Nationwide in the USA
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)