Drug product
Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01
D-0626-2018
Product summary
- Event
- Event 79640
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16 paper cartons
- Official record key
drug-enforcement:D-0626-2018
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Code information: Lot # 116289, Exp. 09/20
Distribution pattern: FL, VA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing