FDA Recall
Terminated
Historical recordClass III
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37
by GlaxoSmithKline LLC
- Reason
- Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
by Rising Pharma Holding, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.
by Bryant Ranch Prepack, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1.
by Bryant Ranch Prepack, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1.
by Bryant Ranch Prepack, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.
by Bryant Ranch Prepack, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
by Bryant Ranch Prepack, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
- Published
- June 12, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Danisco USA Inc.
- Product
- Grindsted Yogurt 7133 Stabilizer System, 22.68 kg / 50 lb ba…
- Reason
- Potential Salmonella Contamination
- Published
- June 12, 2024
- Distribution
- US: AZ, CA, CO, FL, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Danisco USA Inc.
- Product
- Germantown Gard (A) Preservative, 25 kg / 55.12 lb bag
- Reason
- Potential Salmonella Contamination
- Published
- June 12, 2024
- Distribution
- US: AZ, CA, CO, FL, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Danisco USA Inc.
- Product
- Grindsted Creamer 1817 Stabilizer System, 22.68 kg / 50 lb b…
- Reason
- Potential Salmonella Contamination
- Published
- June 12, 2024
- Distribution
- US: AZ, CA, CO, FL, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Danisco USA Inc.
- Product
- Grindsted Iced Coffee 6752 Stabilizer System, 22.68 kg / 50…
- Reason
- Potential Salmonella Contamination
- Published
- June 12, 2024
- Distribution
- US: AZ, CA, CO, FL, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Danisco USA Inc.
- Product
- Yogurt 6626 Stabilizer System, 22.68 kg / 50 lb bag
- Reason
- Potential Salmonella Contamination
- Published
- June 12, 2024
- Distribution
- US: AZ, CA, CO, FL, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Danisco USA Inc.
- Product
- Grindsted Sour Cream 6563 non-GM Stabilizer System 20 kg/ 44…
- Reason
- Potential Salmonella Contamination
- Published
- June 12, 2024
- Distribution
- US: AZ, CA, CO, FL, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Danisco USA Inc.
- Product
- Grindsted SSD 6242 Stabilizer System, 22.68 kg/ 50 lb bag
- Reason
- Potential Salmonella Contamination
- Published
- June 12, 2024
- Distribution
- US: AZ, CA, CO, FL, IA, ID, IL, IN, KS,…
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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