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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 65020
Product Type Veterinary
Status Ongoing
Recalling Firm Nora Apothecary and Alternative Therapies, Inc.
City Indianapolis
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-22
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern IN, OH, IL, FL, TN

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cyclosporine Opth Oint 0.2%: 3 gm, 6 gm Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 3 V-183-2013
Cyclosporine Opth Oint 0.2%, 6 gm Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 2 V-184-2013
Cyclosporine Opth Soln 0.2%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 5 V-185-2013
Cyclosporine Opth Soln 1%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 4 V-186-2013
Cyclosporine Opth Soln 2%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 2 V-187-2013
EDTA Opth Soln 1%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 1 V-188-2013
Tacrolimus Opth Soln 0.01%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. V-189-2013
Tacrolimus Opth Soln 0.02%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 2 V-190-2013
Idoxuridine Opth Soln 0.1%,5 ml Opthalmic, 30 day expiration Products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. 1 V-191-2013
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