FDA Recall
TerminatedTerminated: May 31, 2023Historical recordClass II
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
by Epic Pharma, LLC
- Reason
- Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
- Published
- October 16, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 23, 2021Historical recordClass II
DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
by Unipharma, Llc.
- Reason
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 16, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 23, 2021Historical recordClass II
DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
by Unipharma, Llc.
- Reason
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass II
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
by Morton Grove Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
- Published
- October 16, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 14, 2023Historical recordClass II
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
by Sandoz, Inc
- Reason
- CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- Published
- October 16, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 14, 2023Historical recordClass II
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
by Sandoz, Inc
- Reason
- CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- Published
- October 16, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 14, 2023Historical recordClass II
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
by Sandoz, Inc
- Reason
- CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- Published
- October 16, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 5, 2021Historical recordClass II
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
by GCP Laboratories Inc
- Reason
- Microbial Contamination of Non-Sterile Product.
- Published
- October 16, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 14, 2020Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Premo and Fresh Grab brands Tuna Salad, refrigerated 5 oz.…
- Reason
- FDA environmental sampling returned a positive test result for Listeria monocytogenes.
- Published
- October 16, 2019
- Distribution
- FL IL IN KY MD MI OH PA TN WI…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 14, 2020Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Premo and Fresh Grab brands Egg Salad, refrigerated 5 oz. w…
- Reason
- FDA environmental sampling returned a positive test result for Listeria monocytogenes.
- Published
- October 16, 2019
- Distribution
- FL IL IN KY MD MI OH PA TN WI…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 14, 2020Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Premo and Fresh Grab brands Chicken Salad, refrigerated 5 o…
- Reason
- FDA environmental sampling returned a positive test result for Listeria monocytogenes.
- Published
- October 16, 2019
- Distribution
- FL IL IN KY MD MI OH PA TN WI…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 14, 2020Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Fresh Grab brand Turkey No Cheese, refrigerated 5 oz. wheat…
- Reason
- FDA environmental sampling returned a positive test result for Listeria monocytogenes.
- Published
- October 16, 2019
- Distribution
- FL IL IN KY MD MI OH PA TN WI…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 14, 2020Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Fresh Grab brand Ham & Cheese, refrigerated 5 oz. wheat bre…
- Reason
- FDA environmental sampling returned a positive test result for Listeria monocytogenes.
- Published
- October 16, 2019
- Distribution
- FL IL IN KY MD MI OH PA TN WI…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 14, 2020Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Premo brand Bologna & Cheese Wedge, refrigerated 5 oz. wedg…
- Reason
- FDA environmental sampling returned a positive test result for Listeria monocytogenes.
- Published
- October 16, 2019
- Distribution
- FL IL IN KY MD MI OH PA TN WI…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 30, 2020Historical recordClass II
Abbott Laboratories
- Product
- Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula…
- Reason
- Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.
- Published
- October 16, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 1, 2022Historical recordClass II
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
by Akorn, Inc.
- Reason
- Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
- Published
- October 9, 2019
- 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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