Melatonin ER 0.5 mg caplet recall: CGMP Deviations
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Why was Melatonin ER 0.5 mg 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: M975 Bulk Lots: 19E058
- Product
- Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Quantity
- 955,928 tablets
- Distribution
- Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
- Recall date
- February 16, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (food)