Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIGlauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIFungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIEdema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIDragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIDragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIDeafness Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IICardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIBone Fixer, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIBaby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIAwake, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIAsthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugHerbal Doctor RemediesClass IIAsma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- 2019-08-14FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIMometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
- 2019-08-14FDA-DrugAAA Pharmaceutical, Inc.Class IIISmart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
- 2019-08-14FDA-DrugAmerican Health PackagingClass IIILovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- 2019-08-07FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IDrospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
Failed dissolution specifications : failed results at the 3-month stability time point.
- 2019-08-07FDA-DrugPiramal Critical Care, Inc.Class IIGablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
- 2019-08-07FDA-DrugLNK International, Inc.Class IIEquate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
Microbial contamination of non-sterile product
- 2019-08-07FDA-DrugMAJOR PHARMACEUTICALSClass IIDIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- 2019-08-07FDA-DrugAmerican Health PackagingClass IIDoxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
Failed Dissolution Specifications: Out of specification result for the dissolution test.
- 2019-08-07FDA-DrugH J Harkins Company Inc dba Pharma PacClass IINeomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
- 2019-08-07FDA-DrugImprimisRx NJClass IITimolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
Subpotent Drug
- 2019-08-07FDA-DrugImprimisRx NJClass IITimolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
Subpotent Drug
- 2019-08-07FDA-DrugWise PharmacyClass IIPapaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
- 2019-08-07FDA-DrugWise PharmacyClass IIPapaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
- 2019-08-07FDA-DrugWise PharmacyClass IIPapaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
- 2019-08-07FDA-DrugWise PharmacyClass IIPapaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
- 2019-08-07FDA-DrugWise PharmacyClass IIPapaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
- 2019-08-07FDA-DrugWise PharmacyClass IIPapaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
- 2019-08-07FDA-DrugWise PharmacyClass IITobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
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