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glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 Sout...

FDA Recall #D-0952-2023 — Class II — July 14, 2023

Recall #D-0952-2023 Date: July 14, 2023 Classification: Class II Status: Terminated

Product Description

glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1

Reason for Recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Recalling Firm

Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Classification

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

Product Type

Drugs

Product Quantity

770 Syringes

Distribution

Nationwide in the USA

Code Information

Lot: 36-247022, Exp 08/07/2023; 36-239877, Exp 07/13/2023; 36-241448, Exp 07/20/2023; 36-251782, Exp 08/29/2023

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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