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Class II: temporary or reversible health riskTerminated

Pharmaceutical Associates Cyproheptadine HCl Syrup Recall

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Ph…

Pharmaceutical Associates Inc · Greenville, SC

Risk level
Class II
Reported by FDA
Nov 12, 2014
Recall ID
D-0240-2015
Check your lot numberHow we source this data

Summary

Pharmaceutical Associates recalled Cyproheptadine HCl Syrup starting Oct 16, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0240-2015 on Nov 12, 2014. Reason: Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Product description

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10

Lot numbers, UPCs & expiration codes

Lot 3H43, Exp. 02/15

Where it was sold

Nationwide

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-0240-2015
Classification
Class II
Status
Terminated
Recall initiated
Oct 16, 2014
FDA report date
Nov 12, 2014
Quantity
9,640 unit dose cups
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmaceutical Associates Inc

Original FDA data

Every field from FDA enforcement report D-0240-2015, exactly as published.

Show all FDA fields
City
Greenville
State
SC
Status
Terminated
Country
United States
Event ID
69547
Address
201 Delaware St
Code information
Lot 3H43, Exp. 02/15
Postal code
29605-5823
Report date
Nov 12, 2014
Product type
Drugs
Recall number
D-0240-2015
Classification
Class II
Recalling firm
Pharmaceutical Associates Inc
Product quantity
9,640 unit dose cups
Termination date
Jun 14, 2017
Reason for recall
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
Distribution pattern
Nationwide
Recall initiation date
Oct 16, 2014
Initial firm notification
Letter
Center classification date
Nov 6, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0240-2015, published Nov 12, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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