Drug Recall Report - Community Health Plan of Washington - Medicare Advantage

The Drug Recall Report is for prescription drugs that are have recently been issued recalls by the U.S. Food and Drug Administration (FDA). Here’s what you should do if your prescription medications are recalled:  

  • Do not continue to use any recalled prescription medicine
  • Contact your provider or pharmacist if you have experienced any reactions.
  • Check your prescription label for the drug lot number and the expiration date to see if any of your medication is affected by the recall.
  • If you have the medication, contact the pharmacy that you received it from. Any adverse actions or events from the use of prescription drugs should be reported to FDA here or calling 1-800-FDA-0178.

Stay up to date with current recall notices by visiting the FDA website  

Relpax 40mg Tablet

On 10/14/2019, Pfizer Inc. recalled Relpax 40mg tablets due to potential microbial contamination of non-sterile products. The U.S. Food and Drug Administration (FDA) has issued a recall of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Relpax 40mg Tablet
NDC Number:                 
0049-2340-45, 0049-2340-05
Lot Numbers:                 
AR5407, CD4565
Expiration Date:           
 02/22

Ranitidine Hydrochloride (HCL)

On 09/23/2019, SANDOZ recalled RANITIDINE HCL due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Ranitidine 150mg and Ranitidine 300mg
NDC Number:                 
00781285560, 00781286531
Lot Numbers:                 
HD8625, HD9275, HU2207, HX6676, HX6677, HC9266, HD1865, HP9441, JK7994, JK8659, HD1862, HP9438, HP9439, HP9440
Expiration Date:            
4/30/2020, 4/30/2020, 8/31/2020, 3/31/2021, 3/31/2021, 4/30/2020, 4/30/2020, 9/30/2020, 8/31/2021, 8/31/2021, 4/30/2020, 9/30/2020, 9/30/2020, 9/30/2020

Losartan Potassium/Hydrochlorothiazide 

On 9/19/2019, Torrent Pharma, Inc., recalled Losartan Potassium (all strengths) and Losartan Potassium/Hydrochlorothiazide (all strengths) due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Losartan Potassium and Losartan Potassium/Hydrochlorothiazide
NDC Number:                 
13668-409-10, 13668-115-90, 13668-115-10, 13668-116-90, 13668-118-90
Lot Numbers:                 
4DU2E009, 4DU3E009, 4DU3D018, BEF7D051, 4P04D007
Expiration Date:            
12/31/2020, 02/28/2021

View past recalls still in effect:

Clobazam Oral Suspension 2.5mg/mL

On 7/16/2019, Bionpharma, Inc. recalled Clobazam Oral Suspension 2.5mg/mL due to out-of-specification results for Microbial Enumeration Tests. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall can be found on the FDA website.

The detailed information of the recalled product is listed below:

Recalled Drug:                 Clobazam Oral Suspension 2.5mg/mL
NDC Number:                 
69452-116-45
Lot Numbers:                 
18246
Expiration Date:            
09/2020

Hydrocodone/Chlorpheniramine 10/8mg/5ml

On 07/11/2019, Tris Pharma, Inc. recalled Hydrocodone/Chlorpheniramine 10/8mg/5mL due to incorrect potency. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall can be found on the FDA website.

The detailed information of the recalled product is listed below:

Recalled Drug:                 Hydrocodone/Chlorpheniramine 10/8mg/5mL
NDC Number:                  27808-086-02
Lot Numbers:                 
14079
Expiration Date:            
10/2021 

Losartan

On 5/3/2019, Heritage Pharmaceuticals Inc. and Torrent Pharma Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On 2/28/2019, Camber Pharmaceuticals Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On 4/10/2019, Torrent Pharma, Inc. recalled Losartan potassium tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171978

The detailed information of the recalled product is listed below:

Recalled drug: Losartan 25mg, 50mg, 100 mg tablets | Losartan Potassium Tablets (all strengths) 

NDC numbers: 31722070010, 31722070130, 31722070290
Lot numbers:
Due to the high volume of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

Acyclovir 400mg tablets

On 4/25/2019, Zydus Pharmaceuticals recalled Acyclovir 400mg tablets due to a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172494

The detailed information of the recalled product is listed below:

Recalled drug:  Acyclovir 400mg tablets, 100 count bottles
NDC number: 
68382079101
Lot numbers:
Z804517
Expiration date:
11/30/2020

Fentanyl Transdermal Patch, 12mcg/hr

On 4/19/2019, Alvogen, Inc recalled Fentanyl 12mcg/hr transdermal patches due to a packaging mix-up leading to the incorrect strength in respective boxes. The U.S. Food and Drug Administration (FDA) has issued a Recall Class I of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172322

The detailed information of the recalled product is listed below:

Recalled drug: Fentanyl 12mcg/hr transdermal patch
NDC number:
47781042347
Lot numbers and expiration date:
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.

Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg

On 3/1/2019, Apotex Inc. recalled Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg due to a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg
NDC Number:                 
60505418303
Lot Numbers:
                 7DY008A, 7DY009A, 7DY010A, 7DY011A
Expiration Date:            
08/2020 

Irbesartan 300 mg Tablets

On 1/18/2019, Prinston Pharmaceutical Inc. recalled Irbesartan 300mg Tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=170280

The detailed information of the recalled product is listed below:

Recalled Drug: Irbesartan 300mg Tablets
NDC Number:
43547-376-09
Lot Numbers:
331B18009

Quetiapine Fumarate 400mg

On November 14, 2018, ASCEND LABORATORIES recalled QUETIAPINE FUMARATE 400 MG due to the presence of a foreign substance. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. This is an ongoing FDA drug recall.

Recalled Drug: Quetiapine Fumarate 400mg

NDC Number: 67877024801

Lot Number: 7143908

Expiration Date: November 2020

Valsartan, Valsartan-Hydroclorothiazide & Amlodipine-Valsartan

On 1/18/2019, Aurobindo Pharma USA Inc. recalled Valsartan 160mg, 320mg, 40mg, 80mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On November 20, 2018 Mylan recalled Amlodipine-Valsartan &  Valsartan due to the detection of trace amounts of the impurity NDEA (N-Nitrosodiethylamine) found in the active pharmaceutical ingredient of Valsartan. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is available on the FDA website

Recalled Drug: 

  • Valsartan 40 mg, 60 mg, 80 mg, 160 mg, and 320 mg
  • Amlodipine-Valsartan 5/160 mg, 10/160 mg and 10/320 mg
  • Valsartan-Hydrochlorathiazide 320/25 MG 

NDC Number: 65862057290, 65862057390, 65862057030, 65862057190, 00378-1721-93, 00378-1722-93, 00378-1724-93, 00378-5813-77, 00378-5814-77, 00378-5807-93, 0378-5815-77 and 0378-6325-05

Lot Number: 3079500, 3061986, 3079709, 3077618, 3079708, 3063782, 3071352, 3061169, 3081499, 3080009, 3080010, 3079205, 3084886, 3093804

Expiration Date:  November 2018, January 2019, March 2019, July 2019, November 2019, December 2019, January 2020, February 2020, March 2020

Tizanidine HCL 2 mg

On 09/04/2018, Dr. Reddy’s Lab recalled Tizanidine HCL 2 MG due to a tablet mix-up. Glimepiride tablets were found in bottles of Tizanidine.  The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medication.  

Recalled Drug: Tizanidine HCL 2 mg

NDC Number: 55111017915

Lot Numbers: T800304

Expiration Date: 03/2021

Diphenoxylate & Atropine 2.5 mg/0.025mg

On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications.

Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg

NDC Number: 59762-1061-01 and 59762-1061-02

Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834

Expiration Date: 2021 OCT 31, 2021 NOV 30

Fluticasone 50mcg

On 05/31/2018, Apotex Corp recalled Fluticasone 50mcg due to the potential presence of embedded and loose particles within the medication. The U.S. Food and Drug Administration (FDA) has issued a Class 2 recall of the affected medications.

Recalled Drug: Fluticasone 50mcg

NDC Number: 60505-0829-01

Lot Number: NJ4501

Expiration Date: 07/2020

Diphenoxylate and Atropine 2.5 mg/0.025mg

On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg

NDC Number: 59762-1061-01 and 59762-1061-02

Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834

Expiration Date: Oct 31, 2021, Nov 30, 2021

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