Recalls / Class II
Class IID-0807-2018
Product
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
- Affected lot / code info
- Lot # 130128, EXP 08/31/20
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).
Recalling firm
- Firm
- Prescript Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 39 California Ave Ste 104, Pleasanton, California 94566-6279
Distribution
- Quantity
- 24 473-ml bottles
- Distribution pattern
- California.
Timeline
- Recall initiated
- 2018-04-24
- FDA classified
- 2018-05-14
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0807-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.