Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Product description
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.
Lot numbers, UPCs & expiration codes
a) Lot #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17; Lot #: GS007858, Expiry: Nov-17. b) Lot #: GS002674, Expiry: Jan-16; Lot #: GS003402, Expiry:May-16; Lot #: GS003582, Expiry: Jun-16; Lot #: GS004899, Expiry: Jun-16; Lot #: GS005908, Expiry: Jun-17; Lot #: GS006088, Expiry: Jun-17; Lot #: GS006254, Expiry: Sep-17; Lot #: GS007345, Expiry: Nov-17; Lot #: GS007664, Expiry: Nov-17; Lot #: GS007803, Expiry: Nov-17; Lot #: GS008091, Expiry: Nov-17.
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-0510-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 25, 2015
- FDA report date
- Dec 16, 2015
- Quantity
- a) 737 Bottles; b) 3863 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0510-2016, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 72733
- Address
- 5187 Camino Ruiz
- Code information
- a) Lot #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17; Lot #: GS007858, Expiry: Nov-17. b) Lot #: GS002674, Expiry: Jan-16; Lot #: GS003402, Expiry:May-16; Lot #: GS003582, Expiry: Jun-16; Lot #: GS004899, Expiry: Jun-16; Lot #: GS005908, Expiry: Jun-17; Lot #: GS006088, Expiry: Jun-17; Lot #: GS006254, Expiry: Sep-17; Lot #: GS007345, Expiry: Nov-17; Lot #: GS007664, Expiry: Nov-17; Lot #: GS007803, Expiry: Nov-17; Lot #: GS008091, Expiry: Nov-17.
- Postal code
- 93012-8601
- Report date
- Dec 16, 2015
- Product type
- Drugs
- Recall number
- D-0510-2016
- Classification
- Class III
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- a) 737 Bottles; b) 3863 Bottles
- Termination date
- Jun 7, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Nov 25, 2015
- Initial firm notification
- Center classification date
- Dec 4, 2015