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Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratorie...

FDA Recall #D-0546-2022 — Class II — January 26, 2022

Recall #D-0546-2022 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00

Reason for Recall

CGMP Deviations

Recalling Firm

ULTRAtab Laboratories, Inc. — Highland, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

7,983,360 tablets

Distribution

Bulk product was distributed to 3 distributors who may have distributed finished product.

Code Information

Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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