Inspections, Compliance, Enforcement, and Criminal Investigations

Novartis/Alcon Notification of Product Theft

FDA posts press releases and other notices from firms as a service to consumers, the media, and other notified parties.

Date Posted: August 12, 2011

Novartis and its Alcon Division are working with the U.S. Food and Drug Administration (FDA), industry cargo thefts organizations, and law enforcement officials to recover Novartis, Alcon, and Falcon* products that were stolen on July 18, 2011 while being delivered to a customer's distribution center in Florida. The products stolen are listed below and represent a small portion of each product lot, which have already been distributed within the United States, Puerto Rico, and its territories. Products from the below listed lots that were delivered prior to July 18 are not affected by this event.

*Falcon is a line of generic eye care pharmaceuticals from the Sandoz Division of Novartis.

Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for the specified products after the date of the theft, is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or to visit the OCI Web Site (http://www.fda.gov/OCI).

Novartis, Alcon, and Falcon products are delivered in tamper-evident packaging to protect product integrity. Novartis, Alcon, and the FDA advise physicians, retailers, and consumers to purchase product only from trusted and reliable sources and to check all products for signs of tampering or damage prior to purchase and/or use. Do not use the product if the packaging appears to have been disturbed in any way. Be aware that an unusually low price may be an indication that the product may have been stolen. Stolen medicine may be harmful because it may have been stored at the wrong temperature or humidity or other improper conditions, may degrade or lose potency, become contaminated, or may have been tampered with or handled improperly while outside of the legitimate supply chain.

All Novartis, Alcon, and Falcon products are safe and effective when used as directed and purchased from legitimate and reputable retail outlets and pharmacies.

Alcon and Falcon eye care products should only be used after consulting with a licensed eye care professional. Only a licensed eye care professional can properly diagnose and treat eye diseases and eye conditions.

Patient or customer inquiries should be directed to:

  • Novartis Consumer Health Customer Relations at 800-452-0051
  • Alcon/Falcon Customer Service at 800-862-5266
BRAND PRODUCT DESCRIPTION DOSAGE NDC# LOT/BATCH QUANTITY
ALCON I-CAPS AREDS TABLETS (TIME-RELEASE) Nutritional Supplement 120 COUNT N/A 1CR0301 9 CASES
ALCON I-CAPS LUTEIN & ZEAXANTHIN TABLETS Nutritional Supplement 120 COUNT N/A 1ER0141 20 CASES
ALCON OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION OTC Lens Care Solution 10 OZ N/A 183045F 34 CASES
ALCON OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION OTC Lens Care Solution 2 OZ N/A 192174F 25 CASES
ALCON OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION OTC Lens Care Solution 2 x 10 OZ N/A 179296F 1 CASE
ALCON OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION OTC Lens Care Solution 2 x 10 OZ N/A 187037F 10 CASES
ALCON OPTI-FREE REPLENISH OTC Lens Care Solution 10 OZ N/A 177640F 70 CASES
ALCON OPTI-FREE REPLENISH OTC Lens Care Solution 10 OZ N/A 184542F 42 CASES
ALCON OPTI-FREE REPLENISH OTC Lens Care Solution 4 OZ N/A 187821F 24 CASES
ALCON OPTI-FREE REPLENISH REWETTING DROPS OTC Lens Care Solution 10ML N/A 188050F 10 CASES
ALCON SYSTANE 15ML +33% MORE FREE OTC Drug 20ML 0065-0429-84 192417F 60 CASES
ALCON SYSTANE BALANCE OTC Drug 10ML 0065-1433-02 188132F 16 CASES
ALCON SYSTANE NIGHTTIME OTC Drug 3.5GM 0065-0509-35 11D13G 20 CASES
ALCON SYSTANE ULTRA OTC Drug 10ML 0065-1431-05 186583F 41 CASES
ALCON SYSTANE ULTRA BONUS PAK OTC Drug 2 x 10ML 0065-1431-41 187811F 6 CASES
ALCON SYSTANE ULTRA UNIT DOSE OTC Drug 24 x 0.5ML 0065-0432-01 11114A 6 CASES
ALCON SYSTANE UNIT DOSE OTC Drug 28 x 0.4ML 0065-0431-32 11195A 6 CASES
FALCON ATROPINE SULFATE OPHTHALMIC SOLUTION 1% Rx Drug 15ML 61314-303-02 182819F 48 EA.
FALCON BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.15% Rx Drug 10ML 61314-144-10 186814F 240 EA.
FALCON BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.15% Rx Drug 15ML 61314-144-15 184721F 48 EA.
FALCON BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.15% Rx Drug 5ML 61314-144-05 188857F 96 EA.
FALCON DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION 0.1% Rx Drug 5ML 61314-294-05 188840F 48 EA.
FALCON KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% Rx Drug 10ML 61314-126-10 191015F 96 EA.
FALCON KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% Rx Drug 5ML 61314-126-05 191016F 384 EA.
FALCON NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC OINTMENT Rx Drug 3.5GM 61314-631-36 11D26EF 288 EA.
FALCON NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC SUSPENSION Rx Drug 5ML 61314-630-06 185157F 288 EA.
FALCON OFLOXACIN OTIC SOLUTION Rx Drug 5ML 61314-015-05 186980F 672 EA.
FALCON PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION 2% Rx Drug 15ML 61314-204-15 180896F 48 EA.
FALCON PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION 1% Rx Drug 10ML 61314-637-10 190404F 384 EA.
FALCON PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION 1% Rx Drug 5ML 61314-637-05 190367F 1056 EA.
FALCON SULFACETAMIDE SODIUM 10% AND PREDNISOLONE SODIUM PHOSPHATE 0.25% Rx Drug 5ML 61314-297-05 187416F 96 EA.
FALCON TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% Rx Drug 5ML 61314-224-05 186839F 48 EA.
FALCON TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% Rx Drug 5ML 61314-224-05 190390F 288 EA.
FALCON TIMOLOL MALEATE OPHTHALMIC SOLUTION 0.5% Rx Drug 10ML 61314-227-10 184268F 528 EA.
FALCON TIMOLOL MALEATE OPHTHALMIC SOLUTION 0.5% Rx Drug 15ML 61314-227-15 188175F 240 EA.
FALCON TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SOLUTION Rx Drug 10ML 61314-647-10 186824F 144 EA.
FALCON TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SOLUTION Rx Drug 2.5ML 61314-647-25 187402F 144 EA.
FALCON TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SOLUTION Rx Drug 5ML 61314-647-05 188186F 384 EA.
FALCON TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE OPHTHALMIC SOLUTION Rx Drug 10ML 61314-628-10 190394F 528 EA.
NOVARTIS EXCEDRIN EXTRA STRENGTH CAPLETS OTC Drug 250 COUNT 0067-2000-7 10116785 2904 EA.
NOVARTIS GENTEAL SEVERE OPHTHALMIC LUBRICATING GEL OTC Lubricating Ophthalmic Gel 10G 0078-0429 419072 7 CASES

Novartis and its Alcon Division have taken quick and appropriate actions to ensure the safety of their products and will continue to work closely with law enforcement authorities, the FDA, and distribution partners to maintain the integrity of the supply chain.

 

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