FDAClass IIFebruary 16, 2022

Extra-Strength Unaspirin caplet recall: CGMP Deviations

Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00

Why was Extra-Strength Unaspirin caplet recalled?

CGMP Deviations

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?

Product Codes: L207L Bulk Lots: 18K111, 19E104, 19F050

Product
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
Recalling firm
ULTRAtab Laboratories, Inc.
Quantity
6,215,512 tablets
Distribution
Bulk product was distributed to 3 distributors who may have distributed finished product.
Recall date
February 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls