Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Reported: July 3, 2019 Initiated: June 24, 2019 #D-1430-2019
Product Description
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Reason for Recall
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Details
- Recalling Firm
- H J Harkins Company Inc dba Pharma Pac
- Units Affected
- 12 bottles
- Distribution
- Nationwide Within the United States
- Location
- Grover Beach, CA
Frequently Asked Questions
What product was recalled? ▼
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.. Recalled by H J Harkins Company Inc dba Pharma Pac. Units affected: 12 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 3, 2019. Severity: Moderate. Recall number: D-1430-2019.
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