Why it was recalled
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Product description
Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482
Lot numbers, UPCs & expiration codes
Lot # 130128, EXP 08/31/20
Where it was sold
California.
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-0807-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2018
- FDA report date
- May 23, 2018
- Quantity
- 24 473-ml bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prescript Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0807-2018, exactly as published.
Show all FDA fields
- City
- Pleasanton
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79961
- Address
- 39 California Ave Ste 104
- Code information
- Lot # 130128, EXP 08/31/20
- Postal code
- 94566-6279
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0807-2018
- Classification
- Class II
- Recalling firm
- Prescript Pharmaceuticals, Inc.
- Product quantity
- 24 473-ml bottles
- Termination date
- Jan 23, 2019
- Reason for recall
- Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482
- Distribution pattern
- California.
- Recall initiation date
- Apr 24, 2018
- Initial firm notification
- Letter
- Center classification date
- May 14, 2018