Children's Grape Flavored Acetaminophen Oral Suspension recall: CGMP Deviations
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97
Why was Children's Grape Flavored Acetaminophen Oral Suspension recalled?
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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?
Batch: 1BK0960, Exp 12/31/2022
- Product
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97
- Recalling firm
- Perrigo Company PLC
- Quantity
- 4,992 bottles
- Distribution
- Nationwide in the USA
- Recall date
- March 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)