Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency
Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies to this recall. Per the severity rubric, FDA Class I recalls are rated minimum Severe (score 4) because the sub-potent medication may fail to provide intended therapeutic effect, potentially causing serious health consequences.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder for Oral Solution 100mg (Lot # T2200352, expiration 12/31/2024, NDC 43598-477-30) because of sub-potency concerns. The powder discoloration in the affected lot is associated with decreased drug potency.
When a medication is sub-potent, it means the drug does not contain the full amount of active ingredient specified on the label. This can result in treatment failure if patients do not receive the intended therapeutic dose.
Patients currently taking this medication from the affected lot should contact their healthcare provider or pharmacist immediately to discuss their treatment options. Do not stop taking your medication without consulting your doctor first, as this could affect your health.
The recalled product
- Product
- 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.
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- Affected units
- 2,402
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)
- Lot # T2200352
- Exp. 12/31/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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