Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-06-26FDA-DrugTeligent Pharma, Inc.Class IIIBetamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
Failed Impurities/Degradation Specifications
- 2019-06-26FDA-DrugSun Pharmaceutical Industries, Inc.Class IIWal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- 2019-06-26FDA-DrugSun Pharmaceutical Industries, Inc.Class IIWal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- 2019-06-26FDA-DrugSun Pharmaceutical Industries, Inc.Class IIAllergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- 2019-06-26FDA-DrugSun Pharmaceutical Industries, Inc.Class IIAllergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- 2019-06-19FDA-DrugGeritrex, LLCClass IISenna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
- 2019-06-19FDA-DrugGeritrex, LLCClass IISenna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
- 2019-06-19FDA-DrugBaxter Healthcare CorporationClass IISevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
Failed Stability Specifications
- 2019-06-19FDA-DrugSynthetopes IncClass IISn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugSynthetopes IncClass IISn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugSynthetopes IncClass IISn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugSynthetopes IncClass IISn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugSynthetopes IncClass IISulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugSynthetopes IncClass IISn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugSynthetopes IncClass IISn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugSynthetopes IncClass IIPentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
Lack of Processing Controls.
- 2019-06-19FDA-DrugHeritage Pharmaceuticals, Inc.Class IAMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- 2019-06-19FDA-DrugHeritage Pharmaceuticals, Inc.Class IPROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- 2019-06-19FDA-DrugBausch & LombClass IIILotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
Failed Stability Specifications: Out of specification for viscosity.
- 2019-06-19FDA-DrugNovis PR, Inc.Class IPecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16.
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
- 2019-06-19FDA-DrugFresenius Kabi USA, LLCClass IIIOndansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Failed Impurities/Degradation Specifications.
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIBisacodyl Suppositories, Brite Stock, Reese.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIHydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIHydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIRisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IICetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IICetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIAnu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIHemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IILaxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief