D-0147-2017 Class III Terminated
FDA drug recall D-0147-2017 was initiated by West-Ward Pharmaceuticals Corp. on November 4, 2016 and is designated Class III. Reason for recall: Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. The recall status is terminated (terminated June 16, 2017). Affected quantity: 32,102 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 30, 2016
- Initiation Date
- November 4, 2016
- Termination Date
- June 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,102 bottles
Product Description
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
Reason for Recall
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Distribution Pattern
Nationwide
Code Information
Lot #: AS1466A, Exp. Jan 2019