Recall

All recalls8,521 total

F
FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

L
La Fiesta Food Products — La Fiesta PAN RAYADO SAZONADO Bread Crumbs Seasoned, NET WT 8 OZ. (227g), UPC# 032327000887

Firm distributed a Seasoned Bread Crumb product with undeclared allergen (Sesame) not on the label.

L
La Fiesta Food Products — La Fiesta PAN RAYADO Bread Crumbs, NET WT 8 OZ. (227g), UPC# 032327000886

Firm distributed a Bread Crumb product with undeclared allergen (Sesame) not on the label.

G
G
D
T
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

T
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product containe

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

T
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product containe

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

H
T
The W.S. Badger Company, Inc. — BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

A
A
M
T
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b)

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

T
J
Johnson, S C and Son, Inc — babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 8100359213

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

F
FGF, LLC — item 8201814 BAVARIAN PACZKI 66x4OZ, NET WT 14.85 LB

potential for contamination with listeria monocytogenes

F
F
FGF, LLC — item 8201886 FLAVOREDSOUR CREAM CAKE DONUT 72x3OZ, NET WT 12.15 LB

potential for contamination with listeria monocytogenes

F
FGF, LLC — item 8201922 FLAVORED RASPBERRY BISMARK PFD 3OZ, NET WT 13.16 LB

potential for contamination with listeria monocytogenes

F
FGF, LLC — item 8201807 BAVARIAN FILLED DONUT 78x2.75OZ, NET WT 12.07 LB

potential for contamination with listeria monocytogenes

← Previous

Page 143 of 171

Next →