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.
- 2022-04-13FDA-DrugPfizer Inc.Class IIquinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugSandoz, IncClass IIOrphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- 2022-04-13FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIMethylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
Subpotent
- 2022-04-13FDA-DrugRevive Personal Products CompanyClass IIThe Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714.
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
- 2022-04-13FDA-DrugDASH Pharmaceuticals LLCClass IISucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
Labeling: Label Mix-Up
- 2022-04-13FDA-DrugMylan Pharmaceuticals IncClass IITravoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
- 2022-04-13FDA-DrugAdvanced Accelerator Applications USA, Inc.Class IIINETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
- 2022-04-13FDA-DrugMERCK SHARP & DOHME CORPClass IIJanumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA, by Patheon Puerto Rico, Inc. Manati, Puerto Rico, 00674 Bottle (NDC 0006-0575-02), Carton (NDC 0006-0575-03)
Presence of foreign substance: Presence of stainless steel particulates in tablets.
- 2022-04-13FDA-DrugThe Ritedose CorporationClass III23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
- 2022-04-13FDA-DrugVitae Enim Vitae Scientific, Inc.Class IIPHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-13FDA-DrugVitae Enim Vitae Scientific, Inc.Class IIPHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-13FDA-DrugVitae Enim Vitae Scientific, Inc.Class IIPAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-13FDA-DrugVitae Enim Vitae Scientific, Inc.Class IITETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-06FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IMeclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
- 2022-04-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IILansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.
Failed Dissolution Specifications; during long term stability testing.
- 2022-04-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IILansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
Failed Dissolution Specifications; during long term stability testing.
- 2022-04-06FDA-DrugAurolife Pharma, LLCClass IIGlycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass IITESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
Lack of sterility assurance.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass IITESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
Lack of sterility assurance.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass IITESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy
Lack of sterility assurance.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass IITESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
Lack of sterility assurance.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass IITESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar
Lack of sterility assurance.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass IITESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
Lack of sterility assurance.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass II(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Lack of sterility assurance.
- 2022-04-06FDA-DrugDrug Depot, Inc., dba APS PharmacyClass IIGONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Lack of sterility assurance.
- 2022-04-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIClotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
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