Home / Recalls / ULTRAtab Laboratories, Inc. / D-0544-2022

D-0544-2022 Class II Terminated

Recalled by ULTRAtab Laboratories, Inc. — Highland, NY

Recall Details

Product Type: Drugs
Report Date: February 16, 2022
Initiation Date: January 26, 2022
Termination Date: January 7, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,297,709 tablets

Product Description

Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00

Reason for Recall

CGMP Deviations

Distribution Pattern

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

Code Information

Product Codes: M320L Bulk Lots: 18M063, 19G076

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D-0542-2022 Class II — Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab (January 26, 2022)
D-0534-2022 Class II — Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Labora (January 26, 2022)
D-0545-2022 Class II — Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab L (January 26, 2022)