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Showing 1121–1140 of 3363 results

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WAL-DRAM 2 Tablets (Sato) – Subpotent Drug (2019)

Subpotent Drug

Class IIILow

FDAOct 1, 2019Nationwide• Sato Pharmaceutical Inc.

Sankaijo Botanical Laxative (Sato) – Subpotent Formulation (2019)

Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

Class IIILow

FDAOct 1, 2019Nationwide• Sato Pharmaceutical Inc.

Testosterone Cypionate Injection (Arbor) – label mix-up (2019)

Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials

Class IIILow

FDASep 27, 2019Nationwide• Arbor Pharmaceuticals Inc.

Kenzen Calcium Complex (HP Ingredients) – Mislabeling Issue (2019)

Calcium Complex label does not bear a "Contains: milk" advisory in the correct format.

Class IIILow

FDASep 26, 2019Nationwide• HP Ingredients

Benazepril HCl Tablets (Amneal) – tablet contamination (2019)

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Class IIILow

FDASep 24, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Nori Ajitsuke (Wismettac Asian Foods) – Incorrect Species Listing (2019)

Incorrect seafood species listings on product label; product contains skipjack tuna (fish) and krill (shellfish).

Class IIILow

FDASep 24, 2019HI• Wismettac Asian Foods, INC

Ranitidine Tablets 150mg (AuroMedics) – Empty Bottles (2019)

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Class IIILow

FDASep 23, 2019Nationwide• AuroMedics Pharma LLC

Siracha HOT Chili Sauce (Huy Fong Foods) – seal defect (2019)

Firm received complaint of Siracha sauce bulging at top seal and exploding upon removing seal

Class IIILow

FDASep 17, 2019CA, CO, FL +10 more• Huy Fong Foods, Inc

Sodium Chloride Injection (Guerbet) – RFID Labeling Issue (2019)

Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.

Class IIILow

FDASep 13, 2019Nationwide• GUERBET LLC

Selecto Tomato Wraps (Productos La Samaritana) – undeclared color (2019)

Failure to declare FD&C Red #40

Class IIILow

FDASep 13, 2019PR• Productos La Samaritana, Inc.

La Samaritana Tortillas (Productos La Samaritana) – undeclared color (2019)

Failure to declare FD&C Red #40

Class IIILow

FDASep 13, 2019PR• Productos La Samaritana, Inc.

Ethosuximide Capsules (Pfizer) – Incorrect Labeling (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

Class IIILow

FDASep 12, 2019Nationwide• Pfizer Inc.

Zarontin Ethosuximide Capsules (Pfizer) – incorrect labeling (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.

Class IIILow

FDASep 12, 2019Nationwide• Pfizer Inc.