Drug Recall List

Drug Recall List Drug

Recall Details

Metformin HCl Extended Release CGMP Deviation Tablets

Metformin Hydrochloride Extended-Release 00904579461

Clozapine Tablets 06586284605

CGMP Deviation Presence of foreign tablet

Metformin Hydrochloride Extended-release Tablets 06818033607

Aripiprazole Tablets 06233209730

CGMP Deviations Labeling: Label mix up

Last Updated: July 2020 Contact

Date

If you have questions about this recall, Preferred Pharmaceuticals, Inc, 1714-777-3729. If you have questions about this recall, The Time-Cap, Labs Inc, 1631-753-9090 ext 160 If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876 If you have questions about this recall, Lupin Pharmaceuticals Inc., 1866-587-4617. If you have questions about this recall, Alembic Pharmaceuticals Limited, 1-908-393-9604.

July 2020

July 2020

July 2020

July 2020

July 2020

Drug Recall Class* Class II

Class II

Class II

Class II

Class II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nystatin Cream 00316022130 00316022115

metFORMIN HCL ER 07278900930 07278900960 07278900990 07278900993 49483062301 Metformin Hydrochloride Extended-Release Tablets 04948362301

Subpotent Drug CGMP Deviations CGMP Deviations

If you have questions about this recall, Crown Laboratories, Inc., 1-800877-8869. If you have questions about this recall, Amneal Pharmaceuticals., 1-833582-0812.

July 2020

July 2020

If you have questions about this recall, TimeCap Labs,1-631-753-9090 ext 160

July 2020

Class II Class II Class II

Metformin Hydrochloride

CGMP Deviations

If you have questions

July

Class II

Extended - Release Tablets

about this recall, Teva

2020

06203757101

Pharmaceuticals USA, 1-

06203757110

800-545-8800.

06203757701

06203757710

Metformin Hydrochloride

CGMP Deviations

If you have questions

July

Class II

Extended-Release Tablets

about this recall, Amneal 2020

53746017801

Pharmaceuticals, 1-833-

06516217809

582-0812

06516217850

06516217810

53746017901

06516217910

* Drug Recall Class

Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death.

Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious

adverse health consequences is remote.

Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

00537460178

53746017805

53746017810

65162017811

00537460179

65162017901

Heparin Sodium

Subpotent Drug

If you have questions

June

Class II

70004065046

about this recall, SCA

2020

Pharmaceuticals, 1-877-

550-5059.

Irinotecan HCL Injection

Defective Container

If you have questions

June

Class II

00143958301

about this recall, West-

2020

Ward Pharmaceutical

Corp, 1-877-845-0689.

Irinotecan HCL Injection

Defective Container

If you have questions

June

Class II

00143970101

about this recall, West-

2020

Ward Pharmaceutical

Corp, 1-877-845-0689.

metFORMIN HCL ER

CGMP Deviations

If you have questions

June

Class II

04306342830

about this recall, Amneal 2020

04306342860

Pharmaceuticals, 1-833-

04306342890

582-0812

04306342898

04306342893

53746017805

Metformin Hydrochloride

CGMP Deviations

If you have questions

June

Class II

Extended-Release Tablets

about this recall, AVKARE 2020

05026853115

Inc., 1-931-292-6222.

04229161090

* Drug Recall Class

Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death.

Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious

adverse health consequences is remote.

Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

04229161018 04229161036 04229161010

Metformin Hydrochloride Extended-Release Tablets 04229161190 04229161118 04229161150 Metformin Hydrochloride Extended-Release Tablets 06050502601

CGMP Deviations CGMP Deviations

If you have questions

June

about this recall, AVKARE 2020

Inc., 1-931-292-6222.

If you have questions about this recall, Apotex Inc., 1-800-268-4623.

June 2020

Class II Class II

Gaviscon Liquid Antacid Extra Strength, Cool Mint 00135009541

Labeling: Label lacks warning

Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry 00135057441

Labeling: Label lacks warning

Gaviscon Regular Strength Liquid Antacid Cool Mint 00135009441

Labeling: Label lacks warning

If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-7434014 If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-7434014 If you have questions about this recall, Glaxosmithkline Consumer Healthcare

June 2020

June 2020

June 2020

Class II Class II Class II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Gaviscon Regular Strength Liquid Antacid Cool Mint 00135009442

Labeling: Label lacks warning

oxyTOCIN 30 Units 070092106807

Lisinopril 06818051303

Unasyn (ampicillin sodium/sulbacatam) 00049001381 00049001383 Doxycycline Hyclate 06258469311

Subpotent drug Product Mix Up Presence of Particulate Matter Failed dissolution specification

Holdings Inc., 1-800-7434014

If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-7434014 If you have questions about this recall, QuVa Pharma, Inc., 1-888-3390874. If you have questions about this recall, Lupin Pharmaceuticals Inc., 1866-587-4617. If you have questions about this recall, Pfizer Inc., 1-800-879-3477.

June 2020

June 2020

June 2020

June 2020

If you have questions about this recall, American Health Packaging, 1-614492-8177.

June 2020

Class II

Class II Class II Class II Class II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

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