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Showing 5821–5840 of 15081 results

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DrKids Children's Pain Solution (Unipharma) – Bacteria Risk (2019)

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

CVS Children's Fever Liquid (Unipharma) – Bacteria Risk (2019)

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

Articaine Dental (Septodont) – Mislabeling Issue (2019)

Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.

Class IIModerate

FDAMay 2, 2019Nationwide• Septodont Inc.

Life Rising NECK-ND Neck Clear Capsules (Life Rising) – High Lead (2019)

High lead levels in products

Class IIModerate

FDAMay 2, 2019IN• Life Rising Corporation

CVS Children's Mucus Relief (Unipharma) – Bacteria Risk (2019)

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

Life Rising Holder-W Warmer Capsules (Life Rising) – High Lead (2019)

High lead levels in products

FDAMay 2, 2019IN• Life Rising Corporation

CVS Children's Cough Syrup (Unipharma) – Bacteria Risk (2019)

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Preferred Pharmaceuticals) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAApr 30, 2019CA, GA, IN +1 more• Preferred Pharmaceuticals, Inc

Losartan Potassium Tablets (Direct Rx) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer

Class IIModerate

FDAApr 30, 2019GA• Direct Rx

Mycophenolate Mofetil Injection (Par) – Glass Fragment (2019)

Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product

FDAApr 30, 2019Nationwide• Par Pharmaceutical, Inc.

Ketorolac Injection (Sagent Pharmaceuticals) – Microbial Growth (2019)

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Class IIModerate

FDAApr 30, 2019Nationwide• Sagent Pharmaceuticals Inc

Relpax Tablets (Pfizer) – Labeling Error (2019)

Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.

FDAApr 29, 2019Nationwide• Pfizer Inc.

Hydromorphone Injectable Solution (Advanced Pharma) – Sub-potency (2019)

Sub-potency

Class IIModerate

FDAApr 26, 2019Nationwide• Advanced Pharma Inc.

Acyclovir Tablets (Zydus) – Label Mix-up (2019)

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Class IIModerate

FDAApr 25, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pain Relief Cream (TriDerma) – child safety issue (2019)

This recall involves TriDerma Pain Relief Cream with 4% Lidocaine in a jar and tube. The 4 ounce jar is white with a lime green and pink printed label and has a white dome cap. The 2.2 ounce tube is white with a lime green and pink printed label. The lot numbers and expiration dates of the affected products can be found on the bottom of the jar and on the front of the crimped end of the tube. "TriDerma Pain Relief Cream" is printed on the jar and tube. Lot Number Expiration Date 21088 04/2021 20189 04/2021 0738F02A 06/2021 0738F04A 06/2021 0738F04B 06/2021 0738F04C 06/2021 0739A22A 01/2022 0739A22B 01/2022 0739A23A 01/2022

CPSCApr 25, 2019Nationwide• TriDerma, of Corona, Calif.

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