Arizona recalls

FD&C Red No 3 was not declared as an ingredient.

Possible Fragmentation of Ice Cream Tub (Container) Made of Compostable Material.

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.

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

Product may be contaminated with mold.

Undeclared milk

Undeclared milk

Undeclared milk

Undeclared milk

Undeclared sesame and milk

Undeclared milk

Elevated levels of lead

Allergens were declared but the finished product label incorrectly listed ingredients of Almond Croissant.

Finished product label stated cheese in the product name but did not declare milk in the ingredients or allergen statement.

Finished product label stated almond in the product name but did not declare tree nuts or almonds in the ingredients or allergen statement.

Finished product label does not declare sesame which is an ingredient of hummus (tahini).

Finished product label does not declare sesame which is an ingredient of hummus (tahini).

Finished product label stated feta but did not declare milk in the sub-ingredients or allergen 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