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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Alerts for current, active recalls alongside outbreaks and advisories.
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Reports. Newly announced recalls may appear on FDA.gov before they become available in
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Showing 7,881–7,900 of 17,964 drug recalls
Drug RecallTerminatedHistorical recordClass II
CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
by Unipharma, Llc.
Reason
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
by Preferred Pharmaceuticals, 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 at the manufacturer
Recall initiated
April 30, 2019
Reported by FDA
May 22, 2019
Distribution
CA, GA, IN. No DOD/VA accounts. No foreign accounts.
Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.
by Pfizer Inc.
Reason
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
by Alvogen, Inc
Reason
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02
by Sagent Pharmaceuticals Inc
Reason
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.
by Advantice Health
Reason
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
by Advantice Health
Reason
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
by American Health Packaging
Reason
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
