Complete FDA and NHTSA recall records dated in March 2019.
These records include useful source details for the selected month.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
Updates to the Instructions for Use.
Updates to the Instructions for Use.
Undeclared milk. Buttermilk pancake mix which contains milk was packed in Best Choice Pancake & Waffle Complete Mix Original retail cartons which do not declare milk as an ingredient.
Firm received a complaint of a bird foot found in the baked product.
Lamb's Supreme Starz (Star-shaped Hash Brown Patties) are recalled due to contamination with foreign material.
Smoked Silver Salmon product, 6.5 oz. jars and cans, brand Smoked Alaska, is recalled because it has the potential to be contaminated with Clostridium botulinum.
Product contains undeclared sesame seeds.
Firm received a complaint of a bird foot found in the baked product.
Firm received a complaint of a bird foot found in the baked product.
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Lack of Assurance of Sterility
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Subpotent Drug.
Lack of Assurance of Sterility
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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.
