FDAFDA · Food and drugs·Recall number D-1492-2022
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
Published September 14, 2022 · Recall initiated: June 7, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Plastikon Healthcare LLC
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # 21011A, EXP Jan. 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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