Full Press Release Details
National Stock Exchange of India Ltd. (Scrip Code:
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Please find enclosed a Press Release on "Dr.
Reddy's issues voluntary nationwide recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to Sub-potency".
This is for your information and records.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | RICHA PERIWAL richaperiwal@drreddys.com | USHA IYER ushaiyer@drreddys.com |
issues voluntary nationwide recall of
Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
FOR IMMEDIATE RELEASE Hyderabad India and Princeton,
NJ, US; April 23, 2024 - Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its
subsidiaries together referred to as "Dr. Reddy's"), today announced that it is voluntarily recalling six (6) lots of Sapropterin
Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased
potency. The issue was discovered during an accelerated stability test in addition to customer complaints.
Risk Statement: Reduced efficacy of the product
would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely
to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures.
Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart
Dr. Reddy's Laboratories Inc. has not received
any reports of adverse events related to this recall to date.
The product is indicated to reduce blood phenylalanine
(Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-)
responsive Phenylketonuria (PKU) and is packaged in individual packets, 30 per carton. The affected Sapropterin Dihydrochloride Powder
for Oral Solution 100mg lots include the following:
| Product Name | Lot Number | Expiration date | NDC Number |
| Javygtor (Sapropterin Dihydrochloride) Powder for Oral Solution 100 mg | T2202812 | 07/2025 | 43598-097-30 |
| T2204053 | 10/2025 | 43598-097-30 | |
| T2300975 | 02/2026 | 43598-097-30 | |
| T2300976 | 02/2026 | 43598-097-30 | |
| T2304356 | 08/2026 | 43598-097-30 | |
| Sapropterin Dihydrochloride Powder for Oral Solution 100 mg | T2200352 | 12/2024 | 43598-477-30 |
Sapropterin Dihydrochloride Powder for Oral Solution
100 mg was distributed nationwide to wholesalers/retailers.
Reddy's Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns
of all recalled products. Anyone with an existing inventory of the product
being recalled should examine the product and quarantine any of the recalled lots immediately. Consumers who have Sapropterin Dihydrochloride
Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product. Consumers who
have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase.
Consumers with questions regarding this recall can
contact Dr. Reddy's Laboratories Inc. by calling 866-733-3952 during office hours from 9 a.m. to 5 p.m. (EST) Monday through Friday.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or
using this drug product.
Adverse reactions or quality problems experienced
with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by
This recall is being conducted with the knowledge
of the U.S. Food and Drug Administration.
Please click here to see the full prescribing information
for Sapropterin Dihydrochloride Powder for Oral Solution 100 mg.
About Dr. Reddy's: Dr. Reddy's
Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad,
India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of Good
Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars
and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.
Our major markets include - USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep
science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter
of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high
in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
Disclaimer: This press release may include statements
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with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements"
sections of our Annual Report on Form 20-F for the year ended March 31, 2023. The company assumes no obligation to update any information