Why it was recalled
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Product description
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
Lot numbers, UPCs & expiration codes
Lot# 6781202 & 6781302
Where it was sold
Nationwide in the US: CA, OR, WA. Africa.
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-620-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 3, 2013
- FDA report date
- Jul 3, 2013
- Quantity
- 24,048 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kareway Product Inc
Original FDA data
Every field from FDA enforcement report D-620-2013, exactly as published.
Show all FDA fields
- City
- Compton
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 53558
- Address
- 2550 S Dominguez Hills Dr
- Code information
- Lot# 6781202 & 6781302
- Postal code
- 90220-6401
- Report date
- Jul 3, 2013
- Product type
- Drugs
- Recall number
- D-620-2013
- Classification
- Class II
- Recalling firm
- Kareway Product Inc
- Product quantity
- 24,048 cartons
- Termination date
- Oct 28, 2013
- Reason for recall
- Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
- Distribution pattern
- Nationwide in the US: CA, OR, WA. Africa.
- Recall initiation date
- May 3, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2013