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Showing 821–840 of 3363 results

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Sirolimus Tablets 1 mg (American Health) – Impurity Specs (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAMay 12, 2021Nationwide• American Health Packaging

Cequa Eye Solution (Sun Pharmaceutical) – Potency Issue (2021)

Subpotent and Presence of Particulates .

Class IIILow

FDAMay 7, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Peach Slices (Dole) – mislabeled fruit contents (2021)

Cup label identifies product as Peaches, product inside cup, and label on lid is Mixed Fruit

Class IIILow

FDAMay 6, 2021IN, MA, MN +5 more• Dole Packaged Foods, LLC

Atorvastatin Tablets (Dr. Reddy's) – Impurity Specs (2021)

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Class IIILow

FDAMay 4, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Thiamine Injection (Mylan) – Labeling Error (2021)

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

Class IIILow

FDAMay 3, 2021Nationwide• Mylan Institutional LLC

Olmesartan Medoxomil Tablets (Ascend) – Foreign Tablet (2021)

Presence of Foreign Tablet/Capsule

Class IIILow

FDAApr 29, 2021Nationwide• Ascend Laboratories LLC

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

4x6 Acidophilus Capsules (NOW) – undeclared ingredients (2021)

Undeclared Allergen

Foreign capsules included in bottle. Undeclared ingredients.

Class IIILow

FDAApr 28, 2021Nationwide• NOW Health Group Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFELX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Hydrocodone Bitartrate Tablets (KVK-Tech) - impurity specifications (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAApr 27, 2021Nationwide• KVK-Tech, Inc.

Thai Home Sweet Chili Paste (Jansala & Foods) – Manufacturing violation (2021)

Failure to manufacture product in accordance with 21CFR part 114: Acidified Foods

Class IIILow

FDAApr 23, 2021CA, IN, OR +1 more• Jansala & Foods LLC

Acyclovir Tablets (Heritage) – missing lot details (2021)

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIILow

FDAApr 21, 2021OH• Heritage Pharmaceuticals Inc

Evrysdi Oral Solution (Genentech) – defective bottle adapter (2021)

Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.

Class IIILow

FDAApr 20, 2021Nationwide• Genentech Inc

BTREX PLUS Supplements – Damaged Tablets (2021)

cGMP Deviation: Presence of damaged tablets

Class IIILow

FDAApr 20, 2021PR• Lopez Gonzalez Santana Corporation

Asenapine Sublingual 5mg (SigmaPharm) – flavor mix-up (2021)

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Class IIILow

FDAApr 19, 2021Nationwide• SigmaPharm Laboratories LLC

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