Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Reported: February 28, 2018 Initiated: February 9, 2018 #D-0533-2018
Product Description
Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Details
- Recalling Firm
- American Pharmaceutical Ingredients LLC
- Units Affected
- 10000 g
- Distribution
- Nationwide within USA.
- Location
- Waterford, MI
Frequently Asked Questions
What product was recalled? ▼
Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327. Recalled by American Pharmaceutical Ingredients LLC. Units affected: 10000 g.
Why was this product recalled? ▼
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2018. Severity: Moderate. Recall number: D-0533-2018.
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