RemedyRepack Inc. recalls Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430,…
CGMP Deviations: Out of specification for dissolution
Read the official notice →- Date
- 2024-07-24
- Country
- United States
- Brand
- RemedyRepack
- Product
- Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430,…
- Classification
- Class II
- Units
- USA Nationwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 RemedyRepack recalls
- 2025-04-30
US
- 2025-02-12
US
RemedyRepack Inc. recalls Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged…
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- 2025-01-01
US
RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
- 2024-06-19
US
RemedyRepack Inc. recalls Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source…
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- 2024-05-15
US
RemedyRepack Inc. recalls TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a)…
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
- 2023-05-24
US
RemedyRepack Inc. recalls Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc.,…
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Other drugs & medical recalls in the United States
- 2024-07-24
US
Baxter Healthcare Corporation recalls Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent…
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
FDA · DeviceBaxter Healthcare CorporationNationwide distribution. International distribution to Canada, France, and…Official notice →US
Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
US
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC…
Failed Dissolution Specifications: results below specifications
US
Homeocare Laboratories, Inc. recalls STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street,…
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
US
Homeocare Laboratories, Inc. recalls STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500,…
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
US
Fresenius Medical Care Holdings, Inc. recalls DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set,…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.