Plastikon Healthcare LLC: Drug Recall
Recall #D-1493-2022 · 06/07/2022
Class II: Risk
Recall Details
- Recall Number
- D-1493-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Plastikon Healthcare LLC
- Status
- Terminated
- Date Initiated
- 06/07/2022
- Location
- Lawrence, KS, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,464 ampoules
Reason for Recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product Description
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
Distribution Pattern
Distributed Nationwide in the USA
Other Recalls by Plastikon Healthcare LLC
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.