Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
CGMP deviations- Lack of Quality Assurance
- 2017-06-14FDA-DrugQualgenClass IIEstradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
CGMP deviations- Lack of Quality Assurance
- 2017-06-14FDA-DrugMedPark Pharmacy, LLCClass IImethylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
Lack of Assurance of Sterility
- 2017-06-14FDA-DrugL. Perrigo CompanyClass IIOption 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12
Defective Container: Carton is missing the tablet blister strip and tablet.
- 2017-06-14FDA-DrugDr. Reddy's Laboratories, Inc.Class IIZenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81
Failed Dissolution Specifications: out of specification results observed for low dissolution.
- 2017-06-14FDA-DrugDr. Reddy's Laboratories, Inc.Class IIZenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81
Failed Dissolution Specifications: out of specification results observed for low dissolution.
- 2017-06-14FDA-DrugDr. Reddy's Laboratories, Inc.Class IIZenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Failed Dissolution Specifications: out of specification results observed for low dissolution.
- 2017-06-14FDA-DrugDr. Reddy's Laboratories, Inc.Class IIZenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
Failed Dissolution Specifications: out of specification results observed for low dissolution.
- 2017-06-14FDA-DrugSpectrum Laboratory Products, Inc.Class IILevonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
- 2017-06-14FDA-DrugSpectrum Laboratory Products, Inc.Class IIEstradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
- 2017-06-07FDA-DrugForest Laboratories, LLCClass IISaphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIMAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIHYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIfentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIfentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IIfentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IImorphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugSCA PharmaceuticalsClass IImorphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
Lack of assurance of sterility: Product bags leaking at seam.
- 2017-06-07FDA-DrugVistaPharm, Inc.Class IIINystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
- 2017-06-07FDA-DrugSandoz IncClass IIIAmoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
Subpotent Drug; Clavulanic Acid
- 2017-05-31FDA-DrugEnvy MeClass ILaBri's Body Health Atomic, 60 capsules
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
- 2017-05-31FDA-DrugGentell, IncClass IIShield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
GMP Deviations; product may not meet cGMP requirements
- 2017-05-31FDA-DrugCell DistributorsClass IIRefresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
- 2017-05-31FDA-DrugStandard Homeopathic CompanyClass IHyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
- 2017-05-31FDA-DrugStandard Homeopathic CompanyClass IHyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 9006
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
- 2017-05-31FDA-DrugHospira Inc.Class IInfant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
Presence of Particulate Matter: human hair found within an internal sample syringe.
- 2017-05-31FDA-DrugMylan Pharmaceuticals Inc.Class IIINorethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
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