Why it was recalled
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Product description
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Lot numbers, UPCs & expiration codes
Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17
Where it was sold
Distributed to the state of CA and NV.
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-1162-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 5, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 35 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidarex Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-1162-2017, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 78067
- Address
- 595 N Smith Ave Ste B
- Code information
- Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17
- Postal code
- 92880-6920
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1162-2017
- Classification
- Class III
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Product quantity
- 35 bottles
- Termination date
- Dec 4, 2019
- Reason for recall
- Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
- Distribution pattern
- Distributed to the state of CA and NV.
- Recall initiation date
- Sep 5, 2017
- Initial firm notification
- Center classification date
- Sep 13, 2017