FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE MILK CHOCOLATE HEARTS UPC:73490154485
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE CHOCOLATE FLAVORED SPREAD UPC:77245110306 & 815871010…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE PESEK ZMAN SPREAD UPC:815871013079 NET WT. 12.35 oz (…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE CHOCOLATE FLAVORED WAFERS UPC:815871013147 NET WT.…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE GLUTEN FREE CHOCOLATE FLAVORED WAFERS UPC: 81587101316…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE BAZOOKA FRUIT FLAVORED GUM UPC:77245102219 NET WT. 6.3…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE BAZOOKA BAZOOKA FLAVORED GUM UPC:815871012638 NET WT.…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE BAZOOKA GRAPE FLAVORED GUM UPC:815871010467 NET WT.…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE BAZOOKA TUTTI FRUITI FLAVORED GUM UPC:815871010504 NE…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE BAZOOKA BAZOOKA FLAVORED GUM UPC:815871012744 & 81587…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE REFRESHING MINT FLAVORED CHEWING GUM UPC:815871014632…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE SPEARMINT FLAVORED CHEWING GUM UPC:815871014625 NET WT…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE GRAPE GUM WITH SUGAR UPC:815871015998 NET WT. 2.32 (66…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE CHERRY GUM WITH SUGAR UPC:815871016209 NET WT. 2.32oz…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE MUST CHERRY FLAVORED SUGAR FREE CHEWING GUM UPC:772451…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ELITE CONFECTIONERY LTD
- Product
- ELITE MUST LEMON - MINT FLAVORED SUGAR FREE CHEWING GUM UPC:…
- Reason
- Potential contamination with Salmonella
- Published
- June 15, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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