The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1075-2020·Announced 2020-04-08

Morphine 2 mg/mL CADD Cassettes Recalled for Sterility Concerns

Medical Center Pharmacy is recalling Morphine 2 mg/mL CADD Cassettes because production processes cannot assure sterility. Patients in Tennessee who received specific prescriptions should contact their healthcare provider.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Medical Center Pharmacy, Inc. is recalling Morphine 2 mg/mL Cassettes (100 mL CADD Cassette, Rx only, NDC 00409-1134-03). The recall is due to concerns with production processes that cannot assure the sterility of products intended to be sterile.

The affected product is identified by Lot 03032020@34 with a Beyond-Use Date of 03/17/2020. Distribution was limited to specific prescriptions for patients in Tennessee.

Patients who have received this product should contact their healthcare provider for instructions on what to do next.

The recalled product

Product
*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.
Manufacturer
Medical Center Pharmacy, Inc.
Category
Drug — Sterile Injectable
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 03032020@34 BUD: 03/17/2020

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by Medical Center Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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