FDA Recall
Terminated
Historical recordClass I
SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02.
by Adamis Pharmaceuticals Corporation
- Reason
- Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
by Adamis Pharmaceuticals Corporation
- Reason
- Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.
by Macleods Pharma Usa Inc
- Reason
- FAILED CONTENT UNIFORMITY SPECIFICATIONS
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
quinapril 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
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accuretic (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.
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accuretic (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.
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accuretic (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
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accuretic (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.
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
by Sandoz, Inc
- Reason
- CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Subpotent
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
The 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.
by Revive Personal Products Company
- Reason
- 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
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sucralfate 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.
by DASH Pharmaceuticals LLC
- Reason
- Labeling: Label Mix-Up
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
by MYLAN PHARMACEUTICALS INC
- Reason
- 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.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NETSPOT (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
by Advanced Accelerator Applications USA, Inc.
- Reason
- Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Janumet (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)
by MERCK SHARP & DOHME CORP
- Reason
- Presence of foreign substance: Presence of stainless steel particulates in tablets.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
23.4% 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
by The Ritedose Corporation
- Reason
- 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.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENOBARBITAL 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.
by Vitae Enim Vitae Scientific, Inc.
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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