Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796…
CGMP DEVIATIONS
Read the official notice →- Date
- 2023-03-15
- Country
- United States
- Brand
- Denver Solutions, LLC DBA Leiters Health
- Product
- Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood…
- Classification
- Class II
- Units
- Nationwide within the United States including VA or other Government facilities
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Denver Solutions, LLC DBA Leiters Health recalls
- 2025-04-30
USDenver Solutions, LLC DBA Leiters Health recalls Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd,…
Lack of Assurance of Sterility: Leaking/damaged syringes.
- 2024-03-06
- US
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC…
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- 2024-02-07
- US
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark…
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United StatesOfficial notice → - 2023-11-01
- US
- 2021-12-29
- US
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796…
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United StatesOfficial notice →
Other drugs & medical recalls in the United States
- 2023-03-15
- US
Nanomaterials Discovery Corporation recalls Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed…
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
- US
Akron Pharma, Inc. recalls DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Labeling: Incorrect or Missing Lot and/or Exp Date
- US
- US
Teva Pharmaceuticals USA Inc recalls Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL,…
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- US
Nutraceutical Corporation recalls NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp.…
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
- US
Amerisource Health Services LLC recalls Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by:…
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.