Sildenafil Citrate Recall Due to CGMP Deviations
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP 1.00KG bags due to CGMP deviations noted during an FDA inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving manufacturing deviations without confirmed harm.
Plain-English summary
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP, 1.00KG bags, intended for prescription compounding only. The recall was initiated because Current Good Manufacturing Practice (CGMP) deviations were noted during an FDA inspection.
The affected product is identified by Lot SDC2505001 and has an expiration date of April 30, 2030. The product was distributed nationwide in the USA. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their supplier for instructions on return or disposal.
The recalled product
- Product
- SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
- Manufacturer
- Shoolin Pharma Chem LLP
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
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 (3)
- Lot: SDC2505001
- Date of Expiry: April 30
- 2030.
Distribution
Distributed nationwide across the United States.
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