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
Reported: September 14, 2022 Initiated: June 7, 2022 #D-1492-2022
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
Reason for Recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Details
- Recalling Firm
- Plastikon Healthcare LLC
- Units Affected
- 7,200 ampoules
- Distribution
- Distributed Nationwide in the USA
- Location
- Lawrence, KS
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Plastikon Healthcare LLC. Units affected: 7,200 ampoules.
Why was this product recalled? ▼
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2022. Severity: Moderate. Recall number: D-1492-2022.
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