Direct Rx recalls Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90…
cGMP deviations
Read the official notice →- Date
- 2023-04-05
- Country
- United States
- Brand
- Direct Rx
- Product
- Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90…
- Classification
- Class II
- Units
- Nationwide in the USA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Direct Rx recalls
- 2025-04-23
USDirect Rx recalls CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
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
FDA · DrugDirect RxPhysicians and medical facilities in 5 states: AL, CA, FL, GA, IDOfficial notice →- 2024-11-13
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Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA…
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
- 2023-04-12
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Direct Rx recalls Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and…
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- 2023-01-18
- US
Direct Rx recalls Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA…
cGMP deviation: discontinue of stability support for product.
- 2022-09-21
- US
Direct Rx recalls Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo,…
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- 2022-06-08
- US
Direct Rx recalls Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc.…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Other drugs & medical recalls in the United States
- 2023-04-05
- US
Preat Corp recalls Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the…
- US
Ascend Laboratories, LLC recalls Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA,…
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
- US
Apollo Care recalls Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801…
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
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Endo Pharmaceuticals, Inc. recalls Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx…
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
- 2023-03-29
- US
Biomet, Inc. recalls G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
- US
DeRoyal Industries Inc recalls DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of Arizona, Texas, Virginia,…Official notice →