Multi-event March 2020 FDA Recall Drug by Medical Center Pharmacy, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Medical Center Pharmacy, Inc. on March 13, 2020 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Specific prescriptions to patients in TN and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1076-2020
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
03-13-2020
04-08-2020
2 bags
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medical Center Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Specific prescriptions to patients in TN
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
Batch or Lot Expiration Information
Lot# Lot: 03022020@3 BUD: 03/16/2020
Recall Number: D-1074-2020
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
03-13-2020
04-08-2020
1 bottle
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medical Center Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Specific prescriptions to patients in TN
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
Batch or Lot Expiration Information
Lot# Lot: 03042020@7 BUD: 03/18/2020
Recall Number: D-1073-2020
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
03-13-2020
04-08-2020
2 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medical Center Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Specific prescriptions to patients in TN
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
Batch or Lot Expiration Information
Lot# Lot: 03042020@28 BUD: 03/18/2020; 03032020@3 BUD: 03/17/2020
Recall Number: D-1075-2020
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
03-13-2020
04-08-2020
1 cassette
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medical Center Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Specific prescriptions to patients in TN
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: 03032020@34 BUD: 03/17/2020
Recall Number: D-1077-2020
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
03-13-2020
04-08-2020
2 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medical Center Pharmacy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Specific prescriptions to patients in TN
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
Batch or Lot Expiration Information
Lot# Lot: 03022020@5 BUD: 03/16/2020
