Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product description
CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
Lot numbers, UPCs & expiration codes
Lot # 21011A, EXP Jan. 2023
Where it was sold
Distributed Nationwide in the USA
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-1492-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 7, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 7,200 ampoules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-1492-2022, exactly as published.
Show all FDA fields
- City
- Lawrence
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 90398
- Address
- 3780 Greenway Cir
- Code information
- Lot # 21011A, EXP Jan. 2023
- Postal code
- 66046-5440
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1492-2022
- Classification
- Class II
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 7,200 ampoules
- Termination date
- Jun 25, 2025
- Reason for recall
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 7, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 6, 2022