Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted) recall — FDA D-0147-2017
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Complete FDA and NHTSA recall records dated in 2016, organized for browsing by month, category and recalling company.
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Records are ordered by the best available source date.
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
The product was recalled because it may contain almond (tree-nut) and egg and, if eaten, could result in severe allergic reactions in persons sensitive to these ingredients.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
Product label does not declare milk.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
Simply Balanced brand White Chili dry soup mix is recalled because it was contaminated with metal shavings.
The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.
Sun and Sands Enterprise dba Prime Time International is recalling cucumber bushels (Lot 10-1461) because they have the potential to be contaminated with Salmonella.
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.