APAP 500 mg tablet recall: CGMP Deviations
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
Why was APAP 500 mg tablet 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: L210L Bulk Lots: 18L120, 19B044, 19E082
- Product
- APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Quantity
- 6,249,082 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)