Category
Drug and pharmaceutical recalls
17707 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 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.
- 2022-02-09FDA-DrugUltra Seal CorporationClass IISinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IISinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIMIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IISINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
cGMP deviations
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