Recalls / Class II
Class IID-1430-2019
Product
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
- Affected lot / code info
- Lot #: DHI56M, Exp. 12/19
Why it was recalled
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, N/A, Grover Beach, California 93433-4221
Distribution
- Quantity
- 12 bottles
- Distribution pattern
- Nationwide Within the United States
Timeline
- Recall initiated
- 2019-06-24
- FDA classified
- 2019-06-27
- Posted by FDA
- 2019-07-03
- Terminated
- 2023-05-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1430-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.