Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Read the official notice →- Date
- 2022-06-01
- Country
- United States
- Brand
- Direct Rx
- Product
- Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods…
- Classification
- Class II
- Units
- FL
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-01-18
USDirect 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
- 2022-06-01
- US
Direct Rx recalls Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for:…
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- 2022-03-30
- US
Direct Rx recalls Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA…
Defective Container: Leaking containers.
- 2022-03-16
- US
Direct Rx recalls Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct…
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Other drugs & medical recalls in the United States
- 2022-06-01
- US
Calvin Scott & Company, Inc. recalls Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC…
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
- US
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy…
Lack of assurance of sterility.
FDA · DrugOlympia Compounding Pharmacy dba Olympia PharmacyDistributed Nationwide in th USA, Puerto Rico and US Virgin IslandsOfficial notice → - US
GlaxoSmithKline LLC recalls Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
- US
Preferred Pharmaceuticals, Inc. recalls Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- US
Eco Lips, Inc recalls Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%),…
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate…
- US
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for…
Defective Delivery System: customer complaints exceeded respective action limits.