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Class II: temporary or reversible health riskTerminated

Medical Center Pharmacy *Morphine 2 mg/mL Cassette Recall

*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N

Medical Center Pharmacy, Inc. · Cleveland, TN

Risk level
Class II
Reported by FDA
Apr 8, 2020
Recall ID
D-1075-2020
Check your lot numberHow we source this data

Summary

Medical Center Pharmacy recalled *Morphine 2 mg/mL Cassette starting Mar 13, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1075-2020 on Apr 8, 2020. Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Product description

*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.

Lot numbers, UPCs & expiration codes

Lot: 03032020@34 BUD: 03/17/2020

Where it was sold

Specific prescriptions to patients in TN

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1075-2020
Classification
Class II
Status
Terminated
Recall initiated
Mar 13, 2020
FDA report date
Apr 8, 2020
Quantity
1 cassette
Recall type
Voluntary: Firm initiated
Recalling firm
Medical Center Pharmacy, Inc.

Original FDA data

Every field from FDA enforcement report D-1075-2020, exactly as published.

Show all FDA fields
City
Cleveland
State
TN
Status
Terminated
Country
United States
Event ID
85217
Address
2401 N Ocoee St
Code information
Lot: 03032020@34 BUD: 03/17/2020
Postal code
37311-3853
Report date
Apr 8, 2020
Product type
Drugs
Recall number
D-1075-2020
Classification
Class II
Recalling firm
Medical Center Pharmacy, Inc.
Product quantity
1 cassette
Termination date
Oct 14, 2022
Reason for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Voluntary / mandated
Voluntary: Firm initiated
Product description
*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.
Distribution pattern
Specific prescriptions to patients in TN
Recall initiation date
Mar 13, 2020
Initial firm notification
Telephone
Center classification date
Apr 1, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1075-2020, published Apr 8, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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