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(<h1>URGENT: REVISED DRUG RECALL<br /> <em>diphenoxylate hydrochloride and atropine sulfate tablets, USP - CV</sup> </em></h1>)

 URGENT: REVISED DRUG RECALL
diphenoxylate hydrochloride and atropine sulfate tablets, USP – CV

NDC                    Lot Number            Expiration Date             Strength                      Configuration/Count
59762‐1061‐1     R83962                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     R93347                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     R93348                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     R93349                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     R93350                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     R93351                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     R93352                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     S57831                   2021 NOV 30               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     S57832                   2021 NOV 30               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐1     S57834                   2021 NOV 30               2.5 mg/0.025 mg         Bottle containing 100 tablets
59762‐1061‐2     R93356                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 1000 tablets
59762‐1061‐2     R93357                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 1000 tablets
59762‐1061‐2     R93358                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 1000 tablets
59762‐1061‐2     R97310                   2021 OCT 31               2.5 mg/0.025 mg         Bottle containing 1000 tablets
 
Dear Customer:
 
This letter is to inform you of the expansion to the consumer level of the recall previously executed via a letter dated October 25, 2017 by Greenstone LLC, a wholly owned subsidiary of Pfizer Inc, for the above referenced lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent.
 
Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression.
 
The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components. The product label states that over dosage can be life‐threatening and symptoms may include opioid and/or anticholinergic effects including respiratory depression, coma, delirium, lethargy, dryness of the skin and mucous membranes, mydriasis or miosis, flushing, hyperthermia, tachycardia, hypotonia, tachypnea, toxic encephalopathy, seizures and incoherent speech. Respiratory depression has been reported up to 30 hours after ingestion and may recur despite an initial response to narcotic antagonists. The use of the impacted super potent product when used as labeled has a low probability of being associated with adverse events of limited severity such as lethargy, skin flush, and drowsiness. Serious adverse events such as coma and respiratory depression are improbable. If a patient was to receive a sub potent tablet, symptoms may not be controlled. To date, there have been no reports of adverse events related to this recall.
 
FEDERAL REGULATION 21 CFR 7.49 (d) RESPONSIBILITY OF RECIPIENT STATES: “CONSIGNEES THAT RECEIVE A RECALL COMMUNICATION SHOULD IMMEDIATELY CARRY OUT THE INSTRUCTIONS SET FORTH BY THE RECALLING FIRM …” GREENSTONE LLC RECOMMENDS THAT YOU RESPOND TO THIS RECALL, EVEN IF YOU DO NOT HAVE THE RECALLED PRODUCT. TO RESPOND, COMPLETE THE REQUESTED INFORMATION ON THE ENCLOSED  POSTAGE‐PAID  BUSINESS  REPLY  CARD  (BRC)  AND  RETURN  IT,  AS  DIRECTED,  WITHIN  FIVE  (5) BUSINESS DAYS. If you have any questions about responding to this letter, please contact Stericycle Inc. at 1‐855‐ 215‐4982 (Mon.‐Fri. 8 am‐5 pm ET).
 
The recall of the above referenced lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP is being expanded to the Consumer Level. This letter is to notify you of the expansion of this recall to the consumer level.
 
Instructions for Consumers:
Consumers should consult with their health care provider or pharmacy to determine if they have affected product. To return affected product, please contact your pharmacist or Stericycle Inc. at
1‐855‐215‐4982.
 
Consumers with questions regarding this recall can contact Pfizer using the below information. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
 
Contact Information:
Pfizer Medical Information
1‐800‐438‐1985, option 3
(8am to 7pm ET Monday through Friday)
Area of Support:  Medical inquiries
 
Pfizer Safety
1‐800‐438‐1985, option 1
(24 hours a day 7 days per week)
Areas of Support:  To report adverse events or product complaints
 
Instructions for Wholesale and Retail customers:
Our records indicate that you may have received shipment of the affected lots, which were distributed from November 2016 to June 2017. Please check your stock immediately against the table above. If you have any of the affected product in your inventory, please stop distribution immediately and promptly return it to Stericycle Inc.; 2670 Executive Drive, Suite A; Indianapolis, IN 46241; Attn: Event 3399 using the enclosed pre‐paid UPS label. All returns are requested to be completed within six months of this notice date. If you received this notification without the prepaid UPS label and BRC, require additional shipping labels, or have questions regarding the return procedure, please contact Stericycle Inc. at 1‐855‐215‐4982.
 
If you have further distributed any of these lots to other wholesale or retail level accounts please conduct a sub‐ recall to those accounts and communicate this recall information immediately. Please request that they immediately cease distribution of the affected lots and promptly return the product directly to the  above Stericycle Inc. address.   Your accounts do not need to fill out a BRC; however, if they have inventory of the affected product, they can contact Stericycle Inc. at 1‐855‐215‐4982 to obtain pre‐paid shipping labels for product returns. Further authorization is not required for product returns.
 
For pharmacies or health care providers that have dispensed product to consumer customers, please notify these customers regarding this recall.
 
Reimbursement for the returned product will be made by credit memorandum. If you have any questions regarding the reimbursement, please contact your Greenstone Customer Service Representative at 1‐800‐447‐ 3360 (Mon.‐Fri. 8 am‐4:30 pm ET).
 
If you have any medical questions regarding the product, please contact Medical Information at 1‐800‐438‐1985 (Mon.‐Fri. 8 am‐7 pm ET).
 
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. We appreciate your immediate attention and cooperation, and sincerely regret any inconvenience this action may cause you.
 
Sincerely,
 
 
James R. Cannon General Manager