The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY…
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Read the official notice →- Date
- 2023-11-29
- Country
- United States
- Brand
- Harvard Drug Group LLC dba Major Pharmaceuticals and…
- Product
- Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC…
- Classification
- Class I
- Units
- Nationwide within the United States
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls
- 2024-11-27
USThe Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive,…
Failed Impurity/Degradation Specifications
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide within the United StatesOfficial notice →- 2024-11-20
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet…
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the US.Official notice → - 2024-07-10
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton,…
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide. No foreign consignees.Official notice → - 2024-02-21
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680,…
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…The product was distributed nationwide within the United States.Official notice → - 2023-12-27
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC…
Failed Content Uniformity Specifications
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice → - 2023-06-28
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's…
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice →
Other drugs & medical recalls in the United States
- 2023-11-29
- US
NCS Healthcare of Kentucky Inc recalls Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC…
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
- US
Glenmark Pharmaceuticals Inc., USA recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count…
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
- US
Integrity Bio-Chemicals LLC recalls Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum.…
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
FDA · DrugIntegrity Bio-Chemicals LLCDistributed to one distributor in OK with possibility of further distributionOfficial notice → - 2023-11-22
- US
Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This…
- US
Atrium Medical Corporation recalls Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
ROi CPS LLC recalls Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of…