Why it was recalled
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Product description
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
Lot numbers, UPCs & expiration codes
Lot #: 070717-1
Where it was sold
TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0582-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 19, 2018
- FDA report date
- Mar 14, 2018
- Quantity
- 500 gram jar
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kalchem International, Inc.
Original FDA data
Every field from FDA enforcement report D-0582-2018, exactly as published.
Show all FDA fields
- City
- Lindsay
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 79304
- Address
- 224 S Main St Ste B
- Code information
- Lot #: 070717-1
- Postal code
- 73052-5634
- Report date
- Mar 14, 2018
- Product type
- Drugs
- Recall number
- D-0582-2018
- Classification
- Class II
- Recalling firm
- Kalchem International, Inc.
- Product quantity
- 500 gram jar
- Termination date
- Sep 15, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
- Distribution pattern
- TX
- Recall initiation date
- Feb 19, 2018
- Initial firm notification
- Telephone
- Center classification date
- Mar 7, 2018