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Showing 881–900 of 3363 results

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Glycopyrrolate Injection (Accord) – label mixup (2021)

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

FDAJan 28, 2021Nationwide• Accord Healthcare, Inc.

Oseltamivir Phosphate Suspension (Lupin) – Impurity Specification (2021)

Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

FDAJan 21, 2021Nationwide• Lupin Pharmaceuticals Inc.

Tartar Sauce (House-Autry) – Product Spoilage (2021)

The firm received a consumer complaints that the product was spoiled.

Class IIILow

FDAJan 20, 2021FL, NC, OH +3 more• House-Autry Mills, Inc

Roasted Pistachios (Horizon) – Chemical Excess (2021)

Product may have low levels of imidacloprid in excess of the tolerance of 0.05 ppm.

FDAJan 17, 2021CA, MN• Horizon Nut Company, LLC

Benzphetamine Tablets (Calvin Scott) – Label Mix-Up (2021)

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

FDAJan 15, 2021GA, IN• Calvin Scott & Company, Inc.

Gluten Free Sprouted Rolled Oats (One Degree) - packaging defects (2021)

Rancidity and packaging integrity defects in GF sprouted rolled oats

FDAJan 15, 2021AZ, CA, FL +9 more• One Degree Organic Foods Inc,

Testosterone Cypionate Injection (Sun Pharma) – Incorrect Labeling (2021)

Incorrect Labeling: Incorrect lot number on secondary packaging

FDAJan 11, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Phytonadione Tablets (Bausch) – Impurity Specification (2021)

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

FDAJan 7, 2021Nationwide• Bausch Health Companies, Inc.

Mephyton Tablets (Bausch) – Impurity Specification (2021)

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

FDAJan 7, 2021Nationwide• Bausch Health Companies, Inc.

Oxycodone Oral Solution (Genus) – Foreign Substance (2020)

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

FDADec 23, 2020Nationwide• Genus Lifesciences Inc.

Epinephrine/Lidocaine Solution (Edge) – Incorrect Labeling (2020)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDADec 22, 2020PA• Edge Pharma, LLC

Tacrolimus Capsules (Strides) – Moisture Limit Failure (2020)

Failed Moisture Limits

FDADec 22, 2020PA• Strides Pharma Inc.

Benzhydrocodone Tablets (KVK-Tech) – Impurity Issue (2020)

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

FDADec 18, 2020Nationwide• KVK-Tech, Inc.

Morphine Sulfate Injection (SCA Pharmaceuticals) – sterility concern (2020)

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

FDADec 17, 2020Nationwide• SCA Pharmaceuticals

Succinylcholine Chloride (US Compounding) – labeling error (2020)

Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.

FDADec 16, 2020Nationwide• US Compounding Inc

Darlington Soft Baked Cookies – Undeclared Milk (2020)

An internal quality review found that an ingredient contained a milk derivative, but milk was not declared on the label.

FDADec 4, 2020IL, IN, NY• HS Baking Enterprises LLC DBA Darlington Manufacturing

Organic Green Peas (Meijer Distribution) – Nightshade Risk (2020)

Product may contain nightshade

FDADec 1, 2020IL, IN, KY +2 more• Meijer Distribution

Neostigmine Methylsulfate (US Compounding) – Missing Label (2020)

Labelling: Missing label.

FDANov 25, 2020Nationwide• US Compounding Inc

Scandonest 3% Plain (Novocol) – Labeling Mix-up (2020)

Labeling: Label mix-up

FDANov 20, 2020Nationwide• Novocol Pharmaceutical of Canada, Inc.

Fentanyl Injection (SCA Pharmaceuticals) – Subpotency Risk (2020)

Subpotency: Out-of-specification stability test result for low potency was obtained.

FDANov 20, 2020IN, LA, MO• SCA Pharmaceuticals

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