Why it was recalled
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Product description
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
Lot numbers, UPCs & expiration codes
Lot#: 7H66200103G, Exp 12/19
Where it was sold
U.S.A. Nationwide
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-0219-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 24, 2017
- FDA report date
- Jan 24, 2018
- Quantity
- 968 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shionogi Inc.
Original FDA data
Every field from FDA enforcement report D-0219-2018, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 78851
- Address
- 5770 Shiloh Rd
- Code information
- Lot#: 7H66200103G, Exp 12/19
- Postal code
- 30005-8408
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0219-2018
- Classification
- Class III
- Recalling firm
- Shionogi Inc.
- Product quantity
- 968 bottles
- Termination date
- Feb 28, 2018
- Reason for recall
- Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- May 24, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2018