Washington recalls

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

Undeclared walnut and wheat. Mini Squash Harvest Loaf (UPC 8 55324 00505 3) was mis-labeled as Mini Raspberry Lemon Coffee Cake (UPC 8 57297 00745 4) and therefore wheat flour and walnuts are not declared on label.

Acidified product was manufactured by firm without ODA license.

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Product Contamination

Allergen not listed in the Contains statement: Fish

Undeclared allergen (Fish) Ingredient

Undeclared allergen (Fish) Ingredient

Undeclared soy lecithin and soybean oil on label

Undeclared soy lecithin and soybean oil on label

Product may be contaminated with mold.

Undeclared milk

Undeclared milk

Undeclared milk

Undeclared milk

Undeclared sesame and milk

Undeclared milk

Elevated levels of lead

Label has a Contains statement that is missing milk and coconut (tree nut) that are declared in the ingredients statement.

Undeclared milk

High mold, yeast, and total viable count

Elevated lead levels in cinnamon

High levels of Yeast growth and film on top of jarred Kimchi product.

Products may contain undeclared sesame

Products may contain undeclared sesame

During an inspection by the SCDA the firm was notified that their label does not declare the allergen wheat.

Import Violation

Product Contamination

Undeclared gluten