Why it was recalled
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Product description
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Lot numbers, UPCs & expiration codes
Lot #: 1496059A, Expiry: 08/31/2017; Lot #: AD9848A, Expiry: 11/30/2017
Where it was sold
U.S. 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-1031-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 19, 2016
- FDA report date
- Jun 22, 2016
- Quantity
- 71,340 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Galderma Laboratories, L.P.
Original FDA data
Every field from FDA enforcement report D-1031-2016, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 74209
- Address
- 14501 N Freeway Tx
- Code information
- Lot #: 1496059A, Expiry: 08/31/2017; Lot #: AD9848A, Expiry: 11/30/2017
- Postal code
- 76177
- Report date
- Jun 22, 2016
- Product type
- Drugs
- Recall number
- D-1031-2016
- Classification
- Class III
- Recalling firm
- Galderma Laboratories, L.P.
- Product quantity
- 71,340 Bottles
- Termination date
- Dec 23, 2016
- Reason for recall
- Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- May 19, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2016