Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

FDA Recall #D-0657-2022 — Class II — August 6, 2020

Recall #D-0657-2022 Date: August 6, 2020 Classification: Class II Status: Terminated

Product Description

Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Family Pharmacy of Statesville — Statesville, NC

Classification

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

Product Type

Drugs

Product Quantity

4 bags

Distribution

NC only

Code Information

Lot #: 07272020@2 BUD: 10/25/2020; 07302020@1 BUD: 10/28/2020; 08012020@1 BUD: 10/30/2020

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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