June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMME
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Phar
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercia
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg),
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 13, 2018DrugsFDA
HOSPIRA INC, LAKE FOREST recalls Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (ND
Hazard: Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
June 13, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Mark
Hazard: Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
June 13, 2018DrugsFDA
Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmace
Hazard: Resuspension problems: Out of specification for appearance and resuspendability.
June 13, 2018DrugsFDA
Apotex Inc. recalls Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill
Hazard: Presence of foreign substance: glass particles
June 6, 2018DrugsFDA
Shoreside Enterprises Inc. recalls 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
June 6, 2018DrugsFDA
Shoreside Enterprises Inc. recalls POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribu
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
June 6, 2018DrugsFDA
LUPIN SOMERSET recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel La
Hazard: Labeling: Missing Label
May 30, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-
Hazard: Failed Stability Specifications
May 30, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per c
Hazard: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
May 30, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per c
Hazard: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
May 30, 2018DrugsFDA
Ideaz Llc recalls screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g
Hazard: CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
May 30, 2018DrugsFDA
Ideaz Llc recalls screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141
Hazard: CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
May 30, 2018DrugsFDA
Milbar Laboratories, Inc. recalls Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Hazard: Subpotent
May 30, 2018DrugsFDA
Milbar Laboratories, Inc. recalls T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic La
Hazard: Subpotent
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Fresenius Medical Care Renal Therapies Group, LLC recalls 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 492
Hazard: Lack of Assurance of Sterility
May 30, 2018DrugsFDA
Exela Pharma Sciences LLC recalls Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla
Hazard: Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Mo
Hazard: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination