GKI Foods Dark Chocolate Pretzel Nibs, 15 lbs recall — FDA F-0333-2018
GKI Foods of Brighton, Michigan is voluntarily recalling multiple dark chocolate products because they may contain an undeclared milk allergen.
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GKI Foods of Brighton, Michigan is voluntarily recalling multiple dark chocolate products because they may contain an undeclared milk allergen.
GKI Foods of Brighton, Michigan is voluntarily recalling multiple dark chocolate products because they may contain an undeclared milk allergen.
GMP Deviations: inadequate manufacturing control processes
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium…
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Potential failure of the optical distance sensor due to cable disconnection.
Possible break in the connector of the Force Sensor.
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery…
The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on…
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad…
The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on…
The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad…
Observed instability of the device.
Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 printed on the patient label inside the box.
There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter.
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