Coated Phenylephrine HCl 5mg Tablet recall: CGMP Deviations
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
Why was Coated Phenylephrine HCl 5mg 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: M338 Bulk Lots: 19A070, 19B080, 19J043
- Product
- Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Quantity
- 7,983,360 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)