Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
Shoolin Pharma Chem LLP is recalling Tadalafil USP 1.00 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when structural or manufacturing defects like CGMP deviations are involved.
Plain-English summary
Shoolin Pharma Chem LLP is recalling Tadalafil USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only". The product is identified by NDC 85702-001-08 and CAS NO 171596-29-5. The specific batch involved is TLF2506001, with an expiration date of May 31, 2028. The quantity recalled is 20 bags of 1KG each.
The recall was initiated because Current Good Manufacturing Practice (CGMP) deviations were noted during an FDA inspection. The agency has classified this recall as Class II. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the affected product and contact their supplier or the recalling firm for instructions on return or disposal. This product is intended for prescription compounding only.
The recalled product
- Product
- TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, 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 171596-29-5), 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)
- Batch TLF2506001
- Date of Expiry: May 31
- 2028.
Distribution
Distributed nationwide across the United States.
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