FDA Recall
Terminated
Historical recordClass II
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.
by Ferring Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Crystallization: customer complaints for crystallization in finished product.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Crystallization: customer complaints for crystallization in finished product.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
KAREEM MART INC
- Product
- Kareem Chef Halva with Chocolate 1lb size in plastic tub
- Reason
- Salmonella
- Published
- April 7, 2021
- Distribution
- The recalled Halva were distributed th…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
KAREEM MART INC
- Product
- Kareem Chef Halva with Pistachio 1lb and 2lb sizes in plasti…
- Reason
- Salmonella
- Published
- April 7, 2021
- Distribution
- The recalled Halva were distributed th…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
KAREEM MART INC
- Product
- Kareem Chef Halva 1lb and 2lb sizes in plastic tub
- Reason
- Salmonella
- Published
- April 7, 2021
- Distribution
- The recalled Halva were distributed th…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nuts.com
- Product
- Nuts.com brand Diced Dried Figs packaged in 1lb stand up gus…
- Reason
- Undeclared almonds in diced fig product
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Holiday Home Assorted Treat Toppings, 2.6oz (74g) 3 hanging…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Autumn Assorted Treat Toppings Sprinkles, 2.6oz (74g)…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Rainbow Chip Crunch Sprinkles, 5.25oz (148g) clear pl…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Holiday Mix Sprinkles, 7.6oz (215g) clear plastic bot…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Valentine Chip Crunch Sprinkles, 3.46 oz (98g) clear…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Rainbow Chip Crunch Sprinkles, 5.25 oz (148g) clear p…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
by ICU Medical Inc
- Reason
- Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
- Published
- March 31, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
by Adams.Secret.co
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- March 31, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
by Adams.Secret.co
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- March 31, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mindo Chocolate Makers LLC
- Product
- Mindo COFFEE TOFFEE CHOCOLATE BAR, 75 gram / 2.65oz UPC code…
- Reason
- Undeclared milk
- Published
- March 31, 2021
- Distribution
- Retailers in MI and online
View recall →
FDA Recall
Terminated
Historical recordClass III
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
by Teva Pharmaceuticals USA
- Reason
- Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
by Breckenridge Pharmaceutical, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
- Published
- March 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
by Edge Pharma, LLC
- Reason
- Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
- Published
- March 24, 2021
- 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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