Why it was recalled
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Product description
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
Lot numbers, UPCs & expiration codes
Lot #: a) 6624001 exp 2/16, 6630501 exp 3/16, 6669001 exp 12/16, 6676201 exp 1/17, 6680701 exp 2/17; b) 6624002, 6624201 exp 2/16, 6630601 exp 3/16, 6668901 exp 12/16, 6676001, 6676101 exp 1/17, 6679401, 6679501, exp 2/17
Where it was sold
Nartionwide
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-1280-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 9, 2015
- FDA report date
- Aug 5, 2015
- Quantity
- a) 96,640 bottles; b) 17,808 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
Original FDA data
Every field from FDA enforcement report D-1280-2015, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71684
- Address
- 1100 Orthodox St
- Code information
- Lot #: a) 6624001 exp 2/16, 6630501 exp 3/16, 6669001 exp 12/16, 6676201 exp 1/17, 6680701 exp 2/17; b) 6624002, 6624201 exp 2/16, 6630601 exp 3/16, 6668901 exp 12/16, 6676001, 6676101 exp 1/17, 6679401, 6679501, exp 2/17
- Postal code
- 19124-3168
- Report date
- Aug 5, 2015
- Product type
- Drugs
- Recall number
- D-1280-2015
- Classification
- Class II
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- Product quantity
- a) 96,640 bottles; b) 17,808 bottles
- Termination date
- Oct 13, 2016
- Reason for recall
- cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
- Distribution pattern
- Nartionwide
- Recall initiation date
- Jul 9, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2015