Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Product description
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
Lot numbers, UPCs & expiration codes
Lot #: 3060153, Expiry: 08/31/16
Where it was sold
US Nationwide including Puerto Rico
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-0235-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 2, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 4,609 Packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-0235-2016, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72595
- Address
- 1718 Northrock Ct
- Code information
- Lot #: 3060153, Expiry: 08/31/16
- Postal code
- 61103-1201
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0235-2016
- Classification
- Class III
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 4,609 Packages
- Termination date
- Dec 21, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
- Distribution pattern
- US Nationwide including Puerto Rico
- Recall initiation date
- Nov 2, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2015