FoodJul 31, 2019
C & S Wholesale Grocers UPC: 5290900349 recall — FDA F-1641-2019
Products were not held at an appropriate temperature due to a mechanical malfunction during transportation.
Class IIFDA: TerminatedC & S Wholesale Grocers, Inc.
July 2019 recalls — page 19
These records include useful source details for the selected month.
FoodJul 31, 2019
C & S Wholesale Grocers UPC:1829001271 recall — FDA F-1668-2019
Products were not held at an appropriate temperature due to a mechanical malfunction during transportation.
Class IIFDA: TerminatedC & S Wholesale Grocers, Inc.
FoodJul 31, 2019
C & S Wholesale Grocers DANNON OIKOS TRIPLE ZERO GREEK VANILLA - 5.3OZ/4PK, UPC recall — FDA F-1727-2019
Products were not held at an appropriate temperature due to a mechanical malfunction during transportation.
Class IIFDA: TerminatedC & S Wholesale Grocers, Inc.
DrugJul 31, 2019
Pharma-Natural ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ recall — FDA D-1494-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Ascend Laboratories Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) recall — FDA D-1515-2019
Failed Dissolution Specifications
Class IIFDA: TerminatedAscend Laboratories LLC
DrugJul 31, 2019
Pharma-Natural Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical recall — FDA D-1492-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Pharma-Natural Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. recall — FDA D-1500-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube recall — FDA D-1518-2019
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 31, 2019
Pharma-Natural NEOGEN-D recall — FDA D-1506-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Pharma-Natural Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz recall — FDA D-1501-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Temozolomide Capsules, 5 mg recall — FDA D-1508-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class IIFDA: TerminatedDeva Holding AS - Cerkezkoy Subesi
DrugJul 31, 2019
Temozolomide Capsules, 140 mg recall — FDA D-1511-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class IIFDA: TerminatedDeva Holding AS - Cerkezkoy Subesi
DrugJul 31, 2019
Temozolomide Capsules, 250 mg, 5-count bottle recall — FDA D-1513-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class IIFDA: TerminatedDeva Holding AS - Cerkezkoy Subesi
DrugJul 31, 2019
Pharma-Natural TUSSLIN recall — FDA D-1504-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Pharma-Natural Lid O Creme recall — FDA D-1502-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Pharma-Natural Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical recall — FDA D-1495-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Pharma-Natural LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL recall — FDA D-1499-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
SORBUGEN NR recall — FDA D-1505-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Temozolomide Capsules, 20 mg recall — FDA D-1509-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class IIFDA: TerminatedDeva Holding AS - Cerkezkoy Subesi
DrugJul 31, 2019
Amneal Pharmaceuticals Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count recall — FDA D-1516-2019
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class IIIFDA: TerminatedAmneal Pharmaceuticals, Inc.
DrugJul 31, 2019
Pharma-Natural Workvie Instant Pain Relieving Roll On recall — FDA D-1507-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Pharma-Natural AbeeMed cream recall — FDA D-1493-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class IIFDA: TerminatedPharma-Natural Inc.
DrugJul 31, 2019
Dercher Enterprises, Inc., DBA Gordon MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber recall — FDA D-1528-2019
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Class IIFDA: TerminatedDercher Enterprises, Inc., DBA Gordon Laboratories
DrugJul 31, 2019
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension recall — FDA D-1517-2019
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification…
Class IIFDA: TerminatedTris Pharma Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.