June 3, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., S
Hazard: Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
June 3, 2020DrugsFDA
Wuhan Bingbing Pharmaceutical Co., Ltd. recalls Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy,
Hazard: CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
June 3, 2020DrugsFDA
Wuhan Bingbing Pharmaceutical Co., Ltd. recalls Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 8950
Hazard: CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
June 3, 2020DrugsFDA
Wuhan Bingbing Pharmaceutical Co., Ltd. recalls LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceut
Hazard: CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
June 3, 2020DrugsFDA
Wuhan Bingbing Pharmaceutical Co., Ltd. recalls LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/
Hazard: CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
June 3, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-1
Hazard: Failed dissolution specifications
June 3, 2020DrugsFDA
West-Ward Columbus Inc recalls Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 014
Hazard: Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
May 27, 2020DrugsFDA
West-Ward Columbus Inc recalls Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatonto
Hazard: Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
May 27, 2020DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville
Hazard: Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
May 27, 2020DrugsFDA
Mylan Institutional LLC recalls Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC,
Hazard: Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
May 27, 2020DrugsFDA
ICU Medical Inc recalls LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-795
Hazard: Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
May 20, 2020DrugsFDA
MasterPharm LLC recalls Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm
Hazard: Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
May 20, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ
Hazard: Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
May 20, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07
Hazard: Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
May 20, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07
Hazard: Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
May 20, 2020DrugsFDA
The Harvard Drug Group recalls Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:
Hazard: Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
May 13, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pha
Hazard: CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
May 13, 2020DrugsFDA
Sandoz, Inc recalls Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distribut
Hazard: Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
May 6, 2020DrugsFDA
B. Braun Medical Inc recalls Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc.
Hazard: Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
May 6, 2020DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laborato
Hazard: Discoloration: product contains brown pellets
May 6, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Brid
Hazard: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
April 29, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 2
Hazard: Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
April 29, 2020DrugsFDA
Yusef Manufacturing Laboratories, LLC recalls PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.co
Hazard: Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
April 29, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21
Hazard: Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
April 29, 2020DrugsFDA
Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufacture
Hazard: Defective Delivery System: Out of specification for mechanical peel and shear.
April 29, 2020DrugsFDA
Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufacture
Hazard: Defective Delivery System: Out of specification for mechanical peel and shear.
April 29, 2020DrugsFDA
Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactur
Hazard: Defective Delivery System: Out of specification for mechanical peel and shear.
April 22, 2020DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count b
Hazard: cGMP Deviations
April 22, 2020DrugsFDA
B & B Pharmaceuticals, Inc. recalls Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-990
Hazard: cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
April 22, 2020DrugsFDA
Filltech USA, LLC recalls Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a)
Hazard: Microbial contamination of non-sterile products: positive test for yeast and bacteria.