dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx,...

FDA Recall #D-0302-2022 — Class II — November 12, 2021

Recall #D-0302-2022 Date: November 12, 2021 Classification: Class II Status: Terminated

Product Description

dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

SterRx, LLC — Plattsburgh, NY

Classification

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

Product Type

Drugs

Product Quantity

24300 bags

Distribution

U.S.A. Nationwide

Code Information

Lots S21164/BTV, 3-Dec-21; S21191/BUU, 18-DEC-21; S21197/BUZ, 31-Dec-21; S21220/BVV, 13-Jan-22; S21271/BX0, 27-Jan-22; S21272/BXP, 28-Jan-22; S21299/BYP, 18-Fev-22; S21300/BYQ, 19-Feb-22

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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