Category
Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IINormed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIAPAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIMigrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IICoated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIPhenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIEphedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IINutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IISpearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IITrial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IICherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIPeppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIHPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIAPAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIAPAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIExtra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IICoated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IINormed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IICoated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIAPAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIAPAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIAPAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IICoated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIDologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIKramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class IIZee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class II4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
CGMP Deviations
- 2022-02-16FDA-DrugULTRAtab Laboratories, Inc.Class II3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
CGMP Deviations
- 2022-02-09FDA-DrugTeva Pharmaceuticals USAClass IIIMimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42
Mislabeling
- 2022-02-09FDA-DrugTeva Pharmaceuticals USAClass IIIMimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28
Mislabeling
- 2022-02-09FDA-DrugTeva Pharmaceuticals USAClass IITretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
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