FDA Recall
Terminated
Historical recordClass III
Betamethasone 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
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Wal-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
by Sun Pharmaceutical Industries, Inc.
- Reason
- Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Wal-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
by Sun Pharmaceutical Industries, Inc.
- Reason
- Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Allergy 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
by Sun Pharmaceutical Industries, Inc.
- Reason
- Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Allergy 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
by Sun Pharmaceutical Industries, Inc.
- Reason
- Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
APS BioGroup, Inc
- Product
- Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Su…
- Reason
- The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
APS BioGroup, Inc
- Product
- DPS Throat Spray, UPC 8 55602 00021 3. Colostrum Immune Conc…
- Reason
- The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
APS BioGroup, Inc
- Product
- Viralox, UPC 8 63784 00015 0. Immune Balancing Ploypeptide O…
- Reason
- The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
APS BioGroup, Inc
- Product
- Immuno PRP Spray, UPC 8 12527 01176 2. Colostrum Polypeptide…
- Reason
- The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Milk Chocolate Butter Almond Toffee, 6 oz.…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Dark Chocolate Sea Salt Caramels, 7 oz. 1 u…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Milk Chocolate Covered Pecan Caramel Cluster…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Milk Chocolate Covered Peanut Butter Pretzel…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Senna (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
by Geritrex, LLC
- Reason
- Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
by Geritrex, LLC
- Reason
- Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
by Baxter Healthcare Corporation
- Reason
- Failed Stability Specifications
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 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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