Denison Pharmaceuticals, LLC recalls Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products…
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Read the official notice →- Date
- 2024-06-26
- Country
- United States
- Brand
- Denison Pharmaceuticals
- Product
- Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc.,…
- Classification
- Class II
- Units
- Recalled units were distributed to one customer. 100% recovered (113,544…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Denison Pharmaceuticals recalls
- 2025-03-19
USDenison Pharmaceuticals, LLC recalls Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE,…
Chemical Contamination: Presence of benzene.
- 2024-11-13
- US
Denison Pharmaceuticals, LLC recalls Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package…
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
FDA · DrugDenison Pharmaceuticals, LLCProduct was distributed to two accounts that may have distributed the product…Official notice → - 2023-06-07
- US
Denison Pharmaceuticals, LLC recalls Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated,…
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Other drugs & medical recalls in the United States
- 2024-06-26
- US
Consumer Product Partners, LLC recalls Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4;…
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
- US
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin…
Failed Content Uniformity Specifications
- US
MexHealth LLC recalls OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados,…
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
- US
Eugia US LLC recalls Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ…
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
- US
Eugia US LLC recalls Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics…
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- 2024-06-19
- US
Young Dental Manufacturing I, LLC recalls Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
FDA · DeviceYoung Dental Manufacturing I, LLCUS Nationwide distribution in the state of TN.Official notice →