Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.
Reported: April 1, 2020 Initiated: March 6, 2020 #D-1059-2020
Product Description
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.
Reason for Recall
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Details
- Recalling Firm
- Nostrum Laboratories Inc
- Units Affected
- 4722 bottles
- Distribution
- TN, MO
- Location
- Kansas City, MO
Frequently Asked Questions
What product was recalled? ▼
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.. Recalled by Nostrum Laboratories Inc. Units affected: 4722 bottles.
Why was this product recalled? ▼
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 1, 2020. Severity: Moderate. Recall number: D-1059-2020.
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