Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 116289, Exp. 09/20
Where it was sold
FL, VA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0626-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 19, 2018
- FDA report date
- Apr 18, 2018
- Quantity
- 16 paper cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lake Erie Medical & Surgical Supply Inc
Original FDA data
Every field from FDA enforcement report D-0626-2018, exactly as published.
Show all FDA fields
- City
- Holland
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 79640
- Address
- 6920 Hall St
- Code information
- Lot # 116289, Exp. 09/20
- Postal code
- 43528-9485
- Report date
- Apr 18, 2018
- Product type
- Drugs
- Recall number
- D-0626-2018
- Classification
- Class III
- Recalling firm
- Lake Erie Medical & Surgical Supply Inc
- Product quantity
- 16 paper cartons
- Termination date
- Sep 3, 2020
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- FL, VA
- Recall initiation date
- Mar 19, 2018
- Initial firm notification
- Telephone
- Center classification date
- Apr 11, 2018