Recall

All recalls7,877 total

C
B
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Sp

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

C
Chattem Inc — Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

N
A
Amerisource Health Services LLC — Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American He

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

Z
Zydus Pharmaceuticals (USA) Inc — Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

P
Phasor Health, LLC — Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

T
The Coastal Companies DBA Hearn Kirkwood — Turkey BLT on Sourdough Net Wt. 8.94 OZ (253g) in plastic clamshell

Turkey BLT on Sourdough Sandwiches being recalled due to the product having the incorrect sandwich (Peanut Butter & Jelly) in the clamshell container. This incorrect product in the container resulted in an undeclared allergen on the product label (peanuts).

D
Dessert Holdings Llc — favorite day gourmet New York-Style CHEESECAKE 2 SLICES NET WT 6OZ (170 g) UPC 0 85239 09690 1 Target Brands, Inc.

Undeclared Pecan. The firm was notified by their customer that when they were placing the product on the shelves, they noticed the wrong product was in the container.

P
V
Victor Packing Inc. — Dried Cranberries (21.75 lb/case; 300 - 1.16 oz packages/case)

Misbranded - label states 2g total carbohydrates instead of 27g

E
ESAOTE S.P.A. — Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

S
Seabear Company — SeaBear Smokedhouse Alehouse Clam Chowder is packaged in retort pouch, net wt. 12-oz., UPC 0 34507 07021 1. Case label, item 60104, Alehouse Chowder 12/CS.

Recall was initiated due to potential failure of the seal and potential to be contaminated with Clostridium botulinum.

← Previous

Page 125 of 158

Next →