Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr.
Summary
The FDA issued a Class I for Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packet by Dr. Reddy's Laboratories, Inc.. Reason: Sub-potent Drug; powder discoloration associated with decreased potency.
Details
Source
Drug Recall
External ID
D-0486-2024
Action Date
2024-05-15
Status
Ongoing
Category
drug
Product Description
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Lot/Code Info: Lot # T2200352, Exp. 12/31/2024
Quantity Affected: 2402 cartons
Reason for Recall
Sub-potent Drug; powder discoloration associated with decreased potency
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0486-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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