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Showing 801–820 of 3363 results

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Lidocaine Ointment (Teligent) – Viscosity Failure (2021)

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

Class IIILow

FDAJul 29, 2021Nationwide• Teligent Pharma, Inc.

Wickles Relish (Magnolia Vegetable) – Incorrect Label (2021)

Wrong Label applied to Product.

Class IIILow

FDAJul 20, 2021IL, KY, LA +5 more• MAGNOLIA VEGETABLE PROCESSORS

Now Organic Steel Cut Oats – Incorrect Product Label (2021)

Laceration Risk

Specific lot of Organic Steel Cut Oats, may actually contain Organic Beet Sugar

Class IIILow

FDAJul 12, 2021AL, AK, AZ +42 more• NOW Health Group Inc.

Kroger Vitamin D3 Softgels – Unexpected Ingredient (2021)

Vitamin D dietary supplement may contain Coq10

Class IIILow

FDAJul 9, 2021AZ, CO, IN +2 more• Bountiful Trading Inc

Acetaminophen Extra Strength Tablets (LNK) – Incorrect Labeling (2021)

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

Class IIILow

FDAJul 7, 2021IN, PA• LNK International, Inc.

Black Rifle Coffee Mac V (Black Rifle) – Possible Plastic Contamination (2021)

Possible plastic within final product packaging.

Class IIILow

FDAJun 29, 2021TN• Black Rifle Coffee Company

Leukine Injection (Partner Therapeutics) – Stability Failure (2021)

FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.

Class IIILow

FDAJun 23, 2021Nationwide• Partner Therapeutics Inc

Erythromycin Topical Solution (Teligent) – Impurities Concern (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJun 22, 2021Nationwide• Teligent Pharma, Inc.

Erythromycin Topical Gel (Teligent) – Impurities Concern (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJun 22, 2021Nationwide• Teligent Pharma, Inc.

B-Force Homeopathic (Grato) – Superpotent Formulation (2021)

Superpotent

Class IIILow

FDAJun 18, 2021FL• Grato Holdings, Inc.

Brownies (Heidi Remington) – Undeclared Soy (2021)

Soy Lecithin listed in ingredients statement but soy is not mentioned in the contains statement.

Class IIILow

FDAJun 18, 2021IN, OR• Heidi Remington

Phytonadione Tablets (AVKARE) – Impurity Concern (2021)

Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.

Class IIILow

FDAJun 9, 2021CA, IN• AVKARE Inc.

Mephyton (Bausch) - Impurity Specification Failure (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJun 8, 2021Nationwide• Bausch Health Companies, Inc.

Ketamine HCl Injection (Prisma Health) - Incorrect Expiration Date (2021)

Labeling: Incorrect Exp. Date: Incorrect BUD.

Class IIILow

FDAJun 8, 2021IN, SC• Prisma Health Outsourcing Facility

Phytonadione Tablets (Bausch) - Impurity Specification Failure (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJun 8, 2021Nationwide• Bausch Health Companies, Inc.

Atorvastatin Calcium Tablets (Dr. Reddy's) - Impurity Detection (2021)

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

Class IIILow

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

Levetiracetam Tablets (McKesson) - Barcode Error (2021)

Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam

Class IIILow

FDAMay 26, 2021Nationwide• McKesson Corporation dba McKesson Drug Company