Sapropterin Dihydrochloride Powder Recall for Subpotent Drug
Dr. Reddy's Laboratories is recalling Sapropterin Dihydrochloride Powder for Oral Solution (100 mg) nationwide due to out-of-specification assay results indicating the product contains less active ingredient than labeled.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with out-of-specification results indicating a manufacturing quality defect. No illnesses, injuries, or hospitalization reports are stated in the source. The hazard is reduced potency of the active ingredient, which is a quality control issue without reported clinical harm, consistent with Moderate severity.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton (NDC: 43598-477-11 for packets, 43598-477-30 for cartons). The recall involves 340 packets distributed nationwide in the USA.
The product is being recalled because out-of-specification results were observed during assay testing of the sapropterin dihydrochloride powder. Assay results indicate the drug product is subpotent, meaning it contains less of the active pharmaceutical ingredient than specified.
Patients using this medication should consult their healthcare provider before discontinuing treatment or taking any action regarding their medication supply. The recalling firm is Dr. Reddy's Laboratories Inc., located in Princeton, NJ. The affected lot is T2100891 with an expiration date of 02/28/2024.
The recalled product
- Product
- Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Pharmaceutical powder
- Hazard
- subpotent-drug
- out-of-specification-assay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- T2100891
- Exp. 02/28/2024
Distribution
Distributed nationwide across the United States.
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