Lupin Pharmaceuticals Inc. recalls Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,…
Out-of-specification impurity test result observed at 18-month long term stability time point.
Read the official notice →- Date
- 2022-01-12
- Country
- United States
- Brand
- Lupin Pharmaceuticals
- Product
- Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD…
- Classification
- Class III
- Units
- Product Distributed in NY and OH.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Lupin Pharmaceuticals recalls
- 2022-06-22
US
Lupin Pharmaceuticals Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD…
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 10 wholesalers/distributors and one mail order…Official notice →- 2022-05-25
US
Lupin Pharmaceuticals Inc. recalls GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Failed Stability Specification
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed nationwide, including Puerto Rico.Official notice →- 2022-05-11
US
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only,…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-01-12
US
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2021-12-08
US
- 2021-11-10
US
Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09)…
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to major distributors who may have further distributed…Official notice →
Other drugs & medical recalls in the United States
- 2022-01-12
US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512,…
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
US
RemedyRepack Inc. recalls Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG:…
Failed Impurities/Degradation Specifications
FDA · DrugRemedyRepack Inc.Product was distributed to two direct accounts in MI and PA.Official notice →US
Ascend Laboratories, LLC recalls Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend…
Failed impurities/degradation specifications
US
Perrigo Company PLC recalls GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic,…
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
US
ULTRAtab Laboratories, Inc. recalls PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined…
CGMP Deviations: failed stability results, inadequate laboratory investigations,
FDA · DrugULTRAtab Laboratories, Inc.Product was distributed to one customer who may have further distributed the…Official notice →US
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.