Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Di... — FDA record D-0650-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
Reason
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Classification
Class II
Recalling firm
Direct Rx
Quantity
16 bottles
Agency-reported status
Terminated
Source record identifier
D-0650-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot #: 19AU1910 Exp. 5/31/22

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

FL, GA, LA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Mar 16, 2022
Recall initiation date
Mar 4, 2022
Center classification date
Mar 10, 2022
Termination date
Dec 2, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records